Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-01-24 @ 6:04 PM
Study NCT ID:
NCT02370251
Status:
COMPLETED
Last Update Posted:
2019-11-25
First Post:
2015-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Compassionate Use of Omegaven in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002779', 'term': 'Cholestasis'}, {'id': 'D012778', 'term': 'Short Bowel Syndrome'}, {'id': 'D020139', 'term': 'Gastroschisis'}, {'id': 'D007409', 'term': 'Intestinal Atresia'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}], 'ancestors': [{'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D004065', 'term': 'Digestive System Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C568345', 'term': 'fish oil triglycerides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kimberly-ernst@ouhsc.edu', 'phone': '405-271-5215', 'title': 'Kimberly Ernst, MD', 'phoneExt': '42039', 'organization': 'University of Oklahoma'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'This was a compassionate use study, using Omegaven as a "last resort" for infants with a direct bilirubin of at least 2 mg/dL at the time of initiation, so these infants were already at higher risk of death and hematological/hepatobiliary morbidity.'}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Omegaven', 'description': 'Children will receive Omegaven at a maximum of 1 g/kg/day upon enrollment in this arm.\n\nOmegaven: Once the direct bilirubin is 2 mg/dL or more x 2 weeks, Intralipid will be switched to Omegaven at 1 g/kg/day. The bilirubin level will be monitored to determine when resolution of cholestasis (DB \\<2 mg/dL) occurs.', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 0, 'seriousNumAtRisk': 52, 'deathsNumAffected': 4, 'seriousNumAffected': 9}], 'seriousEvents': [{'term': 'Elevated INR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated GGT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 5}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Resolution of Cholestasis for Subjects Who Received Omegaven', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Omegaven', 'description': 'Children will receive Omegaven at a maximum of 1 g/kg/day upon enrollment in this arm.\n\nOmegaven: Once the direct bilirubin is 2 mg/dL or more x 2 weeks, Intralipid will be switched to Omegaven at 1 g/kg/day. The bilirubin level will be monitored to determine when resolution of cholestasis (DB \\<2 mg/dL) occurs.'}], 'classes': [{'title': 'Cholestasis resolved within 3 months', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'Cholestasis resolved after 3 months', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Cholestasis not resolved', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within the first 3 months of sole Omegaven use', 'description': 'To determine if Omegaven results in the resolution of cholestasis (DB \\<2 for 2 consecutive weeks)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety Issues for Infants Who Received Omegaven', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Omegaven', 'description': 'Children will receive Omegaven at a maximum of 1 g/kg/day upon enrollment in this arm.\n\nOmegaven: Once the direct bilirubin is 2 mg/dL or more x 2 weeks, Intralipid will be switched to Omegaven at 1 g/kg/day. The bilirubin level will be monitored to determine when resolution of cholestasis (DB \\<2 mg/dL) occurs.'}], 'classes': [{'title': 'Baseline : INR >1.4', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'End of Treatment : INR >1.4', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Baseline : Gamma-Glutamyl Transferase (GGT) >300', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'End of Treatment : GGT >300', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Baseline : High-density Lipoprotein (HDL) <20', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'End of Treatment : HDL <20', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within the first year of use', 'description': 'To determine if Omegaven results in safety issues such as increased bleeding, essential fatty acid deficiency, elevated liver function tests, increased liver and/or intestinal transplant rates, or death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Essential Fatty Acid Deficiency in Infants Who Received Omegaven', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Omegaven', 'description': 'Children will receive Omegaven at a maximum of 1 g/kg/day upon enrollment in this arm.\n\nOmegaven: Once the direct bilirubin is 2 mg/dL or more x 2 weeks, Intralipid will be switched to Omegaven at 1 g/kg/day. The bilirubin level will be monitored to determine when resolution of cholestasis (DB \\<2 mg/dL) occurs.'}], 'classes': [{'categories': [{'title': 'Did not have EFAD', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'EFAD resolved', 'measurements': [{'value': '27', 'groupId': 'OG000'}]}, {'title': 'EFAD not resolved', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within the first month of use', 'description': 'To determine if Omegaven can resolve essential fatty acid deficiency', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Omegaven', 'description': 'Omegaven: Once the direct bilirubin is 2 mg/dL or more x 2 weeks, Intralipid will be switched to Omegaven at 1 g/kg/day.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Received less than 8 days of Omegaven', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Omegaven', 'description': 'Children will receive Omegaven at a maximum of 1 g/kg/day upon enrollment in this arm.\n\nOmegaven: Once the direct bilirubin is 2 mg/dL or more x 2 weeks, Intralipid will be switched to Omegaven at 1 g/kg/day. The bilirubin level will be monitored to determine when resolution of cholestasis (DB \\<2 mg/dL) occurs.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Birth Gestational Age', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '32'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Birth Weight (g)', 'classes': [{'categories': [{'measurements': [{'value': '1410', 'groupId': 'BG000', 'lowerLimit': '859', 'upperLimit': '1768'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'grams', 'dispersionType': 'INTER_QUARTILE_RANGE'}], 'populationDescription': 'Infants who required at least 8 days of Omegaven and death did not occur while on Omegaven.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-19', 'size': 325383, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-10-15T20:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-09-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-19', 'studyFirstSubmitDate': '2015-02-17', 'resultsFirstSubmitDate': '2019-09-25', 'studyFirstSubmitQcDate': '2015-02-17', 'lastUpdatePostDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-19', 'studyFirstPostDateStruct': {'date': '2015-02-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resolution of Cholestasis for Subjects Who Received Omegaven', 'timeFrame': 'Within the first 3 months of sole Omegaven use', 'description': 'To determine if Omegaven results in the resolution of cholestasis (DB \\<2 for 2 consecutive weeks)'}], 'secondaryOutcomes': [{'measure': 'Safety Issues for Infants Who Received Omegaven', 'timeFrame': 'Within the first year of use', 'description': 'To determine if Omegaven results in safety issues such as increased bleeding, essential fatty acid deficiency, elevated liver function tests, increased liver and/or intestinal transplant rates, or death'}, {'measure': 'Essential Fatty Acid Deficiency in Infants Who Received Omegaven', 'timeFrame': 'Within the first month of use', 'description': 'To determine if Omegaven can resolve essential fatty acid deficiency'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Fat Emulsions, Intravenous', 'Parenteral-Nutrition-Associated Liver Disease', 'Cholestasis', 'Omegaven', 'Fish Oil'], 'conditions': ['Total Parenteral Nutrition-induced Cholestasis', 'Cholestasis', 'Short Bowel Syndrome', 'Gastroschisis', 'Intestinal Atresia', 'Infant, Premature, Diseases', 'Cholestasis of Parenteral Nutrition']}, 'descriptionModule': {'briefSummary': 'This is a single-assignment study to evaluate whether Omegaven (IV fish oil) is effective at treating liver disease in children on long-term IV nutrition.', 'detailedDescription': 'Children up to 18 years of age, on parenteral nutrition, with a direct bilirubin level of 2 mg/dL or greater will be eligible to receive Omegaven at a maximum dose of 1 g/kg/day.\n\nUp to 200 children will be eligible for enrollment.\n\nDirect bilirubin levels and other labs will be monitored as well as growth parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Live in or temporarily relocate to Oklahoma\n* Age less than 18 years, both sexes, all races\n* Have a direct bilirubin level of ≥2 mg/dL for two consecutive weeks after at least 14 days of parenteral nutrition\n* Received parenteral lipids at a maximum dose of 1.7 g/kg/day (24 g/kg over the two weeks prior)\n* Are not currently enrolled in another lipid emulsion study\n\nExclusion Criteria:\n\n* Known food allergy to fish\n* Known metabolic disorder of lipid metabolism\n* Active coagulopathies (active bleeding or requiring blood product treatment in the prior 48 hours)\n* Medical condition likely to result in death in the next 30 days'}, 'identificationModule': {'nctId': 'NCT02370251', 'briefTitle': 'Compassionate Use of Omegaven in Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'Fish Oil Lipid Emulsion for the Treatment of Parenteral-Nutrition-Associated Liver Disease in Infants', 'orgStudyIdInfo': {'id': '5451'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Omegaven', 'description': 'Children will receive Omegaven at a maximum of 1 g/kg/day upon enrollment in this arm.', 'interventionNames': ['Drug: Omegaven']}], 'interventions': [{'name': 'Omegaven', 'type': 'DRUG', 'otherNames': ['Fish oil-based lipid', 'Omega-3-fatty acid lipid emulsion'], 'description': 'Once the direct bilirubin is 2 mg/dL or more x 2 weeks, Intralipid will be switched to Omegaven at 1 g/kg/day. The bilirubin level will be monitored to determine when resolution of cholestasis (DB \\<2 mg/dL) occurs.', 'armGroupLabels': ['Omegaven']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': "OU Children's Hospital", 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Kimberly D Ernst, MD, MSMI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Oklahoma, Department of Pediatrics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'collaborators': [{'name': 'OU Medical Center', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}