Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2026-03-25 @ 12:26 PM
Study NCT ID:
NCT02806232
Status:
COMPLETED
Last Update Posted:
2019-11-20
First Post:
2016-06-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Open Label Dose Finding Safety and Efficacy in Children and Infants Infected With Schistosomiasis (S.Mansoni)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012552', 'term': 'Schistosomiasis'}], 'ancestors': [{'id': 'D014201', 'term': 'Trematode Infections'}, {'id': 'D006373', 'term': 'Helminthiasis'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011223', 'term': 'Praziquantel'}], 'ancestors': [{'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'service@emdgroup.com', 'phone': '+49-6151-72-5200', 'title': 'Communication Center', 'organization': 'Merck KGaA, Darmstadt, Germany'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Day 1 to Day 21', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1, Cohort 1: Biltricide (Racemate Praziquantel) 20 mg/kg', 'description': 'Participants received Biltricide (600 mg tablet) administered orally at a dose of 20 milligram per kilogram (mg/kg), three times a day on treatment Day 1.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 25, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Part 1, Cohort 2: Biltricide (Racemate Praziquantel) 40 mg/kg', 'description': 'Participants received Biltricide (600 mg tablet) administered orally at a dose of 40 mg/kg as a single dose on treatment Day 1.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 30, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part 1, Cohort 3: Racemate Praziquantel 40 mg/kg', 'description': 'Participants received Racemate Praziquantel oral dispersible tablet (ODT) (150 mg) administered orally at a dose of 40 mg/kg as a single dose on treatment Day 1.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 29, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Part 1, Cohort 4: Racemate Praziquantel 60 mg/kg', 'description': 'Participants received Racemate Praziquantel ODT (150 mg) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 31, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part 1, Cohort 5: Levo Praziquantel 30 mg/kg', 'description': 'Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 30 mg/kg as a single dose on treatment Day 1.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 28, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Part 1, Cohort 6: Levo Praziquantel 45 mg/kg', 'description': 'Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 45 mg/kg as a single dose on treatment Day 1.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 33, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Part 1, Cohort 7: Levo Praziquantel 60 mg/kg', 'description': 'Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 37, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Part 2, Cohort 8: Levo Praziquantel 50 mg/kg', 'description': 'Participants aged 13-24 months received Levo Praziquantel ODT (150 mg) administered orally at a dose of 50 mg/kg as a single dose on treatment day 1.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 10, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Part 2, Cohort 9: Levo Praziquantel 50 mg/kg', 'description': 'Participants aged 3 to 12 months received Levo Praziquantel ODT (150 mg) administered orally at a dose of 50 mg/kg as a single dose on treatment day 1.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 22}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 18}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 22}, {'groupId': 'EG006', 'numAtRisk': 60, 'numAffected': 29}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 60, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 60, 'numAffected': 8}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Malaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 14}, {'groupId': 'EG006', 'numAtRisk': 60, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}], 'seriousEvents': [{'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Clinical Cure Determined by Kato-Katz Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '57', 'groupId': 'OG005'}, {'value': '58', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1, Cohort 1: Biltricide (Racemate Praziquantel) 20 mg/kg', 'description': 'Participants received Biltricide (600 mg tablet) administered orally at a dose of 20 milligram per kilogram (mg/kg), three times a day on treatment Day 1.'}, {'id': 'OG001', 'title': 'Part 1, Cohort 2: Biltricide (Racemate Praziquantel) 40 mg/kg', 'description': 'Participants received Biltricide (600 mg tablet) administered orally at a dose of 40 mg/kg as a single dose on treatment Day 1.'}, {'id': 'OG002', 'title': 'Part 1, Cohort 3: Racemate Praziquantel 40 mg/kg', 'description': 'Participants received Racemate Praziquantel oral dispersible tablet (ODT) (150 mg) administered orally at a dose of 40 mg/kg as a single dose on treatment Day 1.'}, {'id': 'OG003', 'title': 'Part 1, Cohort 4: Racemate Praziquantel 60 mg/kg', 'description': 'Participants received Racemate Praziquantel ODT (150 mg) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1.'}, {'id': 'OG004', 'title': 'Part 1, Cohort 5: Levo Praziquantel 30 mg/kg', 'description': 'Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 30 mg/kg as a single dose on treatment Day 1.'}, {'id': 'OG005', 'title': 'Part 1, Cohort 6: Levo Praziquantel 45 mg/kg', 'description': 'Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 45 mg/kg as a single dose on treatment Day 1.'}, {'id': 'OG006', 'title': 'Part 1, Cohort 7: Levo Praziquantel 60 mg/kg', 'description': 'Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1.'}, {'id': 'OG007', 'title': 'Part 2, Cohort 8: Levo Praziquantel 50 mg/kg', 'description': 'Participants aged 13-24 months received Levo Praziquantel ODT (150 mg) administered orally at a dose of 50 mg/kg as a single dose on treatment day 1.'}, {'id': 'OG008', 'title': 'Part 2, Cohort 9: Levo Praziquantel 50 mg/kg', 'description': 'Participants aged 3 to 12 months received Levo Praziquantel ODT (150 mg) administered orally at a dose of 50 mg/kg as a single dose on treatment day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}, {'value': '52', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14-21 days post treatment', 'description': 'Clinical cure was defined as zero egg counts at 14-21 days post treatment as determined by the Kato-Katz method. Number of participants with clinical cure were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intention-to-treat (mITT) analysis set included all participants who had a baseline measurement for the efficacy variable and did not use anti-malaria treatment after study treatment.'}, {'type': 'SECONDARY', 'title': 'Egg Reduction Rate (Percent)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '57', 'groupId': 'OG005'}, {'value': '58', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1, Cohort 1: Biltricide (Racemate Praziquantel) 20 mg/kg', 'description': 'Participants received Biltricide (600 mg tablet) administered orally at a dose of 20 milligram per kilogram (mg/kg), three times a day on treatment Day 1.'}, {'id': 'OG001', 'title': 'Part 1, Cohort 2: Biltricide (Racemate Praziquantel) 40 mg/kg', 'description': 'Participants received Biltricide (600 mg tablet) administered orally at a dose of 40 mg/kg as a single dose on treatment Day 1.'}, {'id': 'OG002', 'title': 'Part 1, Cohort 3: Racemate Praziquantel 40 mg/kg', 'description': 'Participants received Racemate Praziquantel oral dispersible tablet (ODT) (150 mg) administered orally at a dose of 40 mg/kg as a single dose on treatment Day 1.'}, {'id': 'OG003', 'title': 'Part 1, Cohort 4: Racemate Praziquantel 60 mg/kg', 'description': 'Participants received Racemate Praziquantel ODT (150 mg) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1.'}, {'id': 'OG004', 'title': 'Part 1, Cohort 5: Levo Praziquantel 30 mg/kg', 'description': 'Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 30 mg/kg as a single dose on treatment Day 1.'}, {'id': 'OG005', 'title': 'Part 1, Cohort 6: Levo Praziquantel 45 mg/kg', 'description': 'Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 45 mg/kg as a single dose on treatment Day 1.'}, {'id': 'OG006', 'title': 'Part 1, Cohort 7: Levo Praziquantel 60 mg/kg', 'description': 'Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1.'}, {'id': 'OG007', 'title': 'Part 2, Cohort 8: Levo Praziquantel 50 mg/kg', 'description': 'Participants aged 13-24 months received Levo Praziquantel ODT (150 mg) administered orally at a dose of 50 mg/kg as a single dose on treatment day 1.'}, {'id': 'OG008', 'title': 'Part 2, Cohort 9: Levo Praziquantel 50 mg/kg', 'description': 'Participants aged 3 to 12 months received Levo Praziquantel ODT (150 mg) administered orally at a dose of 50 mg/kg as a single dose on treatment day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.6', 'groupId': 'OG000', 'lowerLimit': '89.8', 'upperLimit': '99.4'}, {'value': '83.3', 'groupId': 'OG001', 'lowerLimit': '74.7', 'upperLimit': '91.9'}, {'value': '88.6', 'groupId': 'OG002', 'lowerLimit': '81.8', 'upperLimit': '95.4'}, {'value': '88.6', 'groupId': 'OG003', 'lowerLimit': '82.2', 'upperLimit': '94.9'}, {'value': '88.3', 'groupId': 'OG004', 'lowerLimit': '81.3', 'upperLimit': '95.3'}, {'value': '92.3', 'groupId': 'OG005', 'lowerLimit': '86.4', 'upperLimit': '98.1'}, {'value': '94.1', 'groupId': 'OG006', 'lowerLimit': '88.6', 'upperLimit': '99.6'}, {'value': '97.7', 'groupId': 'OG007', 'lowerLimit': '92.9', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG008', 'lowerLimit': '100.0', 'upperLimit': '100.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, 14-21 days post treatment', 'description': 'Percent reduction in egg count was calculated as geometric mean egg count at post-treatment minus geometric mean egg count at baseline (before treatment) divided by geometric mean egg count at baseline.', 'unitOfMeasure': 'percent reduction in egg count', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT analysis set included all participants who had a baseline measurement for the efficacy variable and did not use anti-malaria treatment after study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Cure Determined by Point-of-Care Circulating Cathodic Antigen (POC-CCA) Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '57', 'groupId': 'OG005'}, {'value': '58', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1, Cohort 1: Biltricide (Racemate Praziquantel) 20 mg/kg', 'description': 'Participants received Biltricide (600 mg tablet) administered orally at a dose of 20 milligram per kilogram (mg/kg), three times a day on treatment Day 1.'}, {'id': 'OG001', 'title': 'Part 1, Cohort 2: Biltricide (Racemate Praziquantel) 40 mg/kg', 'description': 'Participants received Biltricide (600 mg tablet) administered orally at a dose of 40 mg/kg as a single dose on treatment Day 1.'}, {'id': 'OG002', 'title': 'Part 1, Cohort 3: Racemate Praziquantel 40 mg/kg', 'description': 'Participants received Racemate Praziquantel oral dispersible tablet (ODT) (150 mg) administered orally at a dose of 40 mg/kg as a single dose on treatment Day 1.'}, {'id': 'OG003', 'title': 'Part 1, Cohort 4: Racemate Praziquantel 60 mg/kg', 'description': 'Participants received Racemate Praziquantel ODT (150 mg) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1.'}, {'id': 'OG004', 'title': 'Part 1, Cohort 5: Levo Praziquantel 30 mg/kg', 'description': 'Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 30 mg/kg as a single dose on treatment Day 1.'}, {'id': 'OG005', 'title': 'Part 1, Cohort 6: Levo Praziquantel 45 mg/kg', 'description': 'Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 45 mg/kg as a single dose on treatment Day 1.'}, {'id': 'OG006', 'title': 'Part 1, Cohort 7: Levo Praziquantel 60 mg/kg', 'description': 'Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1.'}, {'id': 'OG007', 'title': 'Part 2, Cohort 8: Levo Praziquantel 50 mg/kg', 'description': 'Participants aged 13-24 months received Levo Praziquantel ODT (150 mg) administered orally at a dose of 50 mg/kg as a single dose on treatment day 1.'}, {'id': 'OG008', 'title': 'Part 2, Cohort 9: Levo Praziquantel 50 mg/kg', 'description': 'Participants aged 3 to 12 months received Levo Praziquantel ODT (150 mg) administered orally at a dose of 50 mg/kg as a single dose on treatment day 1.'}], 'classes': [{'title': 'Day 2', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': '14-21 days post treatment', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}, {'value': '42', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 2, Day 8 and 14-21 days post treatment', 'description': 'Clinical Cure defined as no parasite eggs in the stools as assessed by the commercially available POC-CCA assay for S. mansoni. Number of participants with clinical cure were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT analysis set included all participants who had a baseline measurement for the efficacy variable and did not use anti-malaria treatment after study treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1, Cohort 1: Biltricide (Racemate Praziquantel) 20 mg/kg', 'description': 'Participants received Biltricide (600 mg tablet) administered orally at a dose of 20 milligram per kilogram (mg/kg), three times a day on treatment Day 1.'}, {'id': 'FG001', 'title': 'Part 1, Cohort 2: Biltricide (Racemate Praziquantel) 40 mg/kg', 'description': 'Participants received Biltricide (600 mg tablet) administered orally at a dose of 40 mg/kg as a single dose on treatment Day 1.'}, {'id': 'FG002', 'title': 'Part 1, Cohort 3: Racemate Praziquantel 40 mg/kg', 'description': 'Participants received Racemate Praziquantel oral dispersible tablet (ODT) (150 mg) administered orally at a dose of 40 mg/kg as a single dose on treatment Day 1.'}, {'id': 'FG003', 'title': 'Part 1, Cohort 4: Racemate Praziquantel 60 mg/kg', 'description': 'Participants received Racemate Praziquantel ODT (150 mg) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1.'}, {'id': 'FG004', 'title': 'Part 1, Cohort 5: Levo Praziquantel 30 mg/kg', 'description': 'Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 30 mg/kg as a single dose on treatment Day 1.'}, {'id': 'FG005', 'title': 'Part 1, Cohort 6: Levo Praziquantel 45 mg/kg', 'description': 'Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 45 mg/kg as a single dose on treatment Day 1.'}, {'id': 'FG006', 'title': 'Part 1, Cohort 7: Levo Praziquantel 60 mg/kg', 'description': 'Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1.'}, {'id': 'FG007', 'title': 'Part 2, Cohort 8: Levo Praziquantel 50 mg/kg', 'description': 'Participants aged 13-24 months received Levo Praziquantel ODT (150 mg) administered orally at a dose of 50 mg/kg as a single dose on treatment day 1.'}, {'id': 'FG008', 'title': 'Part 2, Cohort 9: Levo Praziquantel 50 mg/kg', 'description': 'Participants aged 3 to 12 months received Levo Praziquantel ODT (150 mg) administered orally at a dose of 50 mg/kg as a single dose on treatment day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '60'}, {'groupId': 'FG003', 'numSubjects': '60'}, {'groupId': 'FG004', 'numSubjects': '60'}, {'groupId': 'FG005', 'numSubjects': '60'}, {'groupId': 'FG006', 'numSubjects': '60'}, {'groupId': 'FG007', 'numSubjects': '20'}, {'groupId': 'FG008', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '59'}, {'groupId': 'FG003', 'numSubjects': '60'}, {'groupId': 'FG004', 'numSubjects': '58'}, {'groupId': 'FG005', 'numSubjects': '58'}, {'groupId': 'FG006', 'numSubjects': '60'}, {'groupId': 'FG007', 'numSubjects': '20'}, {'groupId': 'FG008', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}, {'value': '60', 'groupId': 'BG005'}, {'value': '60', 'groupId': 'BG006'}, {'value': '20', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '444', 'groupId': 'BG009'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1, Cohort 1: Biltricide (Racemate Praziquantel) 20 mg/kg', 'description': 'Participants received Biltricide (600 mg tablet) administered orally at a dose of 20 milligram per kilogram (mg/kg), three times a day on treatment Day 1.'}, {'id': 'BG001', 'title': 'Part 1, Cohort 2: Biltricide (Racemate Praziquantel) 40 mg/kg', 'description': 'Participants received Biltricide (600 mg tablet) administered orally at a dose of 40 mg/kg as a single dose on treatment Day 1.'}, {'id': 'BG002', 'title': 'Part 1, Cohort 3: Racemate Praziquantel 40 mg/kg', 'description': 'Participants received Racemate Praziquantel oral dispersible tablet (ODT) (150 mg) administered orally at a dose of 40 mg/kg as a single dose on treatment Day 1.'}, {'id': 'BG003', 'title': 'Part 1, Cohort 4: Racemate Praziquantel 60 mg/kg', 'description': 'Participants received Racemate Praziquantel ODT (150 mg) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1.'}, {'id': 'BG004', 'title': 'Part 1, Cohort 5: Levo Praziquantel 30 mg/kg', 'description': 'Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 30 mg/kg as a single dose on treatment Day 1.'}, {'id': 'BG005', 'title': 'Part 1, Cohort 6: Levo Praziquantel 45 mg/kg', 'description': 'Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 45 mg/kg as a single dose on treatment Day 1.'}, {'id': 'BG006', 'title': 'Part 1, Cohort 7: Levo Praziquantel 60 mg/kg', 'description': 'Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1.'}, {'id': 'BG007', 'title': 'Part 2, Cohort 8: Levo Praziquantel 50 mg/kg', 'description': 'Participants aged 13-24 months received Levo Praziquantel ODT (150 mg) administered orally at a dose of 50 mg/kg as a single dose on treatment day 1.'}, {'id': 'BG008', 'title': 'Part 2, Cohort 9: Levo Praziquantel 50 mg/kg', 'description': 'Participants aged 3 to 12 months received Levo Praziquantel ODT (150 mg) administered orally at a dose of 50 mg/kg as a single dose on treatment day 1.'}, {'id': 'BG009', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'spread': '1.3', 'groupId': 'BG000'}, {'value': '4.3', 'spread': '1.3', 'groupId': 'BG001'}, {'value': '4.4', 'spread': '1.2', 'groupId': 'BG002'}, {'value': '4.2', 'spread': '1.2', 'groupId': 'BG003'}, {'value': '4.2', 'spread': '1.2', 'groupId': 'BG004'}, {'value': '4.3', 'spread': '1.1', 'groupId': 'BG005'}, {'value': '4.4', 'spread': '1.3', 'groupId': 'BG006'}, {'value': '1.7', 'spread': '0.3', 'groupId': 'BG007'}, {'value': '0.6', 'spread': '0.2', 'groupId': 'BG008'}, {'value': '4.1', 'spread': '1.3', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}, {'value': '25', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '205', 'groupId': 'BG009'}]}, {'title': 'Male', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}, {'value': '28', 'groupId': 'BG005'}, {'value': '35', 'groupId': 'BG006'}, {'value': '13', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '239', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Black or African American', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}, {'value': '60', 'groupId': 'BG005'}, {'value': '60', 'groupId': 'BG006'}, {'value': '20', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '444', 'groupId': 'BG009'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety analysis set included all participants who were exposed to investigative medicinal product.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-31', 'size': 438374, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-10-30T06:49', 'hasProtocol': False}, {'date': '2018-02-28', 'size': 3689188, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-10-30T06:49', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 444}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-11-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-30', 'studyFirstSubmitDate': '2016-06-16', 'resultsFirstSubmitDate': '2019-10-30', 'studyFirstSubmitQcDate': '2016-06-17', 'lastUpdatePostDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-30', 'studyFirstPostDateStruct': {'date': '2016-06-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Clinical Cure Determined by Kato-Katz Method', 'timeFrame': '14-21 days post treatment', 'description': 'Clinical cure was defined as zero egg counts at 14-21 days post treatment as determined by the Kato-Katz method. Number of participants with clinical cure were reported.'}], 'secondaryOutcomes': [{'measure': 'Egg Reduction Rate (Percent)', 'timeFrame': 'Baseline, 14-21 days post treatment', 'description': 'Percent reduction in egg count was calculated as geometric mean egg count at post-treatment minus geometric mean egg count at baseline (before treatment) divided by geometric mean egg count at baseline.'}, {'measure': 'Number of Participants With Clinical Cure Determined by Point-of-Care Circulating Cathodic Antigen (POC-CCA) Test', 'timeFrame': 'Day 2, Day 8 and 14-21 days post treatment', 'description': 'Clinical Cure defined as no parasite eggs in the stools as assessed by the commercially available POC-CCA assay for S. mansoni. Number of participants with clinical cure were reported.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Praziquantel ODT formulation', 'Biltricide'], 'conditions': ['Schistosomiasis']}, 'descriptionModule': {'briefSummary': 'The Phase II study consisted of two parts, part 1 is open label, randomized, controlled and exploratory dose finding in children aged between 2 and 6 years infected with S. mansoni. Part 2 investigated efficacy and safety with the selected formulation and dosage in S. mansoni infected children aged between 3 months - 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female children aged 2 to 6 years (Part 1) and 3 to 24 months (Part 2)\n* S. mansoni positive diagnosis defined as positive egg counts in stool (greater than \\[\\>\\]1 egg/1 occasion) according to World Health Organization (WHO) classification : light (1-99 eggs per gram of faeces), moderate (100-399 eggs per gram of faeces) and heavy (greater than or equal to \\[\\>=\\]400 eggs per gram of faeces) infections\n* Minimum weight of 8.0 kg in 2- to 6-year-old children and of 4.0 kg in 3- to 24-month infants\n\n • Parents/legal representative ability to communicate well with the Investigator, to understand the protocol requirements and restrictions, and willing their children to comply with the requirements of the entire trial, i.e.\n* To be examined by a study physician at screening and 14-21 days after treatment\n* To provide stool and urine samples at screening, 24 hours and 8 days after treatment, as well as 14-21 days after treatment\n* To provide finger prick blood samples for Pharmacokinetics (PK) studies and blood samples for safety assessments\n\nExclusion Criteria:\n\n* Treatment in the 4 weeks prior to study screening with Praziquantel (PZQ) , other anti-helminthic, antimalarial or anti-retroviral compounds or any other medication that might affect the PK of PZQ such as certain antiepileptics (e.g., carbamazepine or phenytoin), glucocorticosteroids (e.g., dexamethasone), chloroquine, rifampicin or cimetidine\n* For children being breast fed, treatment of the mothers/wet nurses with PZQ in the 3 days prior to administration of Investigational medicinal product\n* Previous history of adverse reactions associated with PZQ treatment\n* Marked increases of the liver transaminases (alanine aminotransferase and/or aspartate aminotransferase) above 3x Upper Limit of Normal (ULN)\n* History of acute or severe chronic disease including hepato-splenic schistosomiasis\n* Fever defined as temperature above 38.0 degree centigrade\n* Debilitating illnesses such as tuberculosis, malnutrition, etc. as well as a medical history of seizures\n* Mixed S. haematobium and S. mansoni infections\n* Findings in the clinical examination of schistosome-infected children participating in the study as performed by the study clinician on the treatment day, that in the opinion of the Investigator constitutes a risk or a contraindication for the participation of the subject in the study or that could interfere with the study objectives, conduct or evaluation\n* Unlikelihood to comply with the protocol requirements, instructions and trial-related restrictions, e.g., uncooperative attitude, inability to return for follow-up visits, and improbability of completing the trial'}, 'identificationModule': {'nctId': 'NCT02806232', 'briefTitle': 'An Open Label Dose Finding Safety and Efficacy in Children and Infants Infected With Schistosomiasis (S.Mansoni)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck KGaA, Darmstadt, Germany'}, 'officialTitle': 'Open-label, Dose-finding, 2-parts, Efficacy Phase II Study With Three Formulations (Racemate Raziquantel Commercial Oral Tablets, New Oral Disintegrating Tablets of Racemate Praziquantel and L-praziquantel) in Schistosomiasis (S. Mansoni) Infected Children Aged 2-6 Years (Part 1), Followed by an Assessment of Efficacy and Safety With the Selected Formulation and Dosage in S. Mansoni Infected Infants Aged 3-24 Months (Part 2)', 'orgStudyIdInfo': {'id': '200661-0005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1, Cohort 1: Biltricide (racemate praziquantel) 20 mg/kg', 'description': 'Participants received Biltricide (600 mg tablet) administered orally at a dose of 20 milligram per kilogram (mg/kg), three times a day on treatment Day 1.', 'interventionNames': ['Drug: Biltricide (racemate praziquantel) oral tablets']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1, Cohort 2: Biltricide (racemate praziquantel) 40 mg/kg', 'description': 'Participants received Biltricide (600 mg tablet) administered orally at a dose of 40 mg/kg as a single dose on treatment Day 1.', 'interventionNames': ['Drug: Biltricide (racemate praziquantel) oral tablets']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1, Cohort 3: Racemate Praziquantel 40 mg/kg', 'description': 'Participants received Racemate Praziquantel oral dispersible tablet (ODT) (150 mg) administered orally at a dose of 40 mg/kg as a single dose on treatment Day 1.', 'interventionNames': ['Drug: Racemate Praziquantel ODT']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1, Cohort 4: Racemate Praziquantel 60 mg/kg', 'description': 'Participants received Racemate Praziquantel ODT (150 mg) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1.', 'interventionNames': ['Drug: Racemate Praziquantel ODT']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1, Cohort 5: Levo Praziquantel 30 mg/kg', 'description': 'Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 30 mg/kg as a single dose on treatment Day 1.', 'interventionNames': ['Drug: Levo Praziquantel ODT']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1, Cohort 6: Levo Praziquantel 45 mg/kg', 'description': 'Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 45 mg/kg as a single dose on treatment Day 1.', 'interventionNames': ['Drug: Levo Praziquantel ODT']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1, Cohort 7: Levo Praziquantel 60 mg/kg', 'description': 'Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1.', 'interventionNames': ['Drug: Levo Praziquantel ODT']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2, Cohort 8: Levo Praziquantel 50 mg/kg', 'description': 'Participants aged 13-24 months months received Levo Praziquantel ODT (150 mg) administered orally at a dose of 50 mg/kg as a single dose on treatment day 1.', 'interventionNames': ['Drug: Levo Praziquantel ODT']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2, Cohort 9: Levo Praziquantel 50 mg/kg', 'description': 'Participants aged 3 to 12 months received Levo Praziquantel ODT (150 mg) administered orally at a dose of 50 mg/kg as a single dose on treatment day 1.', 'interventionNames': ['Drug: Levo Praziquantel ODT']}], 'interventions': [{'name': 'Biltricide (racemate praziquantel) oral tablets', 'type': 'DRUG', 'description': 'Biltricide (600 mg tablet) was administered to participants at a dose of 20 mg/kg in Part 1, Cohort 1 and at a dose of 40mg/kg in Part 1, Cohort 2.', 'armGroupLabels': ['Part 1, Cohort 1: Biltricide (racemate praziquantel) 20 mg/kg', 'Part 1, Cohort 2: Biltricide (racemate praziquantel) 40 mg/kg']}, {'name': 'Racemate Praziquantel ODT', 'type': 'DRUG', 'description': 'Racemate Praziquantel (PZQ) (150) mg was administered at a dose of 40 mg/kg in Part 1, Cohort 3 and at a dose of 60 mg/kg in Part 1, Cohort 4.', 'armGroupLabels': ['Part 1, Cohort 3: Racemate Praziquantel 40 mg/kg', 'Part 1, Cohort 4: Racemate Praziquantel 60 mg/kg']}, {'name': 'Levo Praziquantel ODT', 'type': 'DRUG', 'description': 'Levo PZQ (150 mg) was administered at a dose of 30 mg/kg in Part 1 Cohort 5, 45 mg/kg Part 1 Cohort 6, 60 mg/kg Part 1 Cohort 7, 50 mg/kg Part 2 Cohort 8, and 50 mg/kg Part 2 Cohort 9.', 'armGroupLabels': ['Part 1, Cohort 5: Levo Praziquantel 30 mg/kg', 'Part 1, Cohort 6: Levo Praziquantel 45 mg/kg', 'Part 1, Cohort 7: Levo Praziquantel 60 mg/kg', 'Part 2, Cohort 8: Levo Praziquantel 50 mg/kg', 'Part 2, Cohort 9: Levo Praziquantel 50 mg/kg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Darmstadt', 'country': 'Germany', 'facility': 'Please Contact the Communication Center', 'geoPoint': {'lat': 49.87167, 'lon': 8.65027}}], 'overallOfficials': [{'name': 'Medical Responsible', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck KGaA, Darmstadt, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck KGaA, Darmstadt, Germany', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}