Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2026-01-29 @ 2:49 PM
Study NCT ID:
NCT01482403
Status:
COMPLETED
Last Update Posted:
2016-08-05
First Post:
2011-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Mericitabine in Combination With Boceprevir and Pegasys/Copegus in Patients With Chronic Hepatitis C
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], 'ancestors': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012254', 'term': 'Ribavirin'}, {'id': 'C100416', 'term': 'peginterferon alfa-2a'}, {'id': 'C512204', 'term': 'N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide'}, {'id': 'C552098', 'term': "2'-fluoro-2'-methyl-3',5'-diisobutyryldeoxycytidine"}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'dispFirstSubmitDate': '2016-07-08', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-03', 'studyFirstSubmitDate': '2011-11-28', 'dispFirstSubmitQcDate': '2016-07-08', 'studyFirstSubmitQcDate': '2011-11-28', 'dispFirstPostDateStruct': {'date': '2016-07-12', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sustained virological response 12 weeks after treatment (SVR-12)', 'timeFrame': 'up to 60 weeks'}], 'secondaryOutcomes': [{'measure': 'Sustained virological response 4 weeks after treatment', 'timeFrame': 'up to 52 weeks'}, {'measure': 'Virologic response over time', 'timeFrame': '60 weeks'}, {'measure': 'Proportion of patients who develop treatment resistance', 'timeFrame': '60 weeks'}, {'measure': 'Safety (incidence of adverse events)', 'timeFrame': '60 weeks'}, {'measure': 'Pharmacokinetics: trough concentration of RO4995855', 'timeFrame': 'Day 1 and Week 8'}, {'measure': 'Pharmacokinetics: trough concentration of RO5012433', 'timeFrame': 'Day 1 and Week 8'}, {'measure': 'Pharmacokinetics: trough concentration of boceprevir', 'timeFrame': 'Day 1 and Week 8'}]}, 'conditionsModule': {'conditions': ['Hepatitis C, Chronic']}, 'referencesModule': {'references': [{'pmid': '26752189', 'type': 'DERIVED', 'citation': 'Wedemeyer H, Forns X, Hezode C, Lee SS, Scalori A, Voulgari A, Le Pogam S, Najera I, Thommes JA. Mericitabine and Either Boceprevir or Telaprevir in Combination with Peginterferon Alfa-2a plus Ribavirin for Patients with Chronic Hepatitis C Genotype 1 Infection and Prior Null Response: The Randomized DYNAMO 1 and DYNAMO 2 Studies. PLoS One. 2016 Jan 11;11(1):e0145409. doi: 10.1371/journal.pone.0145409. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': 'This randomized, double-blind, multi-center, placebo-controlled, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) in combination with boceprevir and Pegasys/Copegus in patients with chronic hepatitis C infection. The anticipated time on study treatment is up to 48 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, \\>/=18 years of age\n* Chronic hepatitis C infection for at least 6 months duration\n* Hepatitis C genotype 1a or 1b\n* Patients must have discontinued prior hepatitis C treatment at least 12 weeks prior to enrollment in this study\n* Patient showed a previous null response to therapy as defined by \\< 2 log10 IU/mL decrease in viral titer after at least 12 weeks of treatment with PEG-IFN/RBV\n\nExclusion Criteria:\n\n* Hepatitis C infection with a genotype other than genotype 1a or 1b\n* Body mass index \\<18 or \\>/=36\n* Hepatitis A, hepatitis B, or HIV infection\n* Herbal remedies \\</=1 month prior to the first dose of study drug'}, 'identificationModule': {'nctId': 'NCT01482403', 'briefTitle': 'A Study of Mericitabine in Combination With Boceprevir and Pegasys/Copegus in Patients With Chronic Hepatitis C', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Phase II, Randomized, Double-Blind, Multicenter, Parallel Group Study to Evaluate the Sustained Virologic Response of the HCV Polymerase Inhibitor Prodrug RO5024048 in Combination With Boceprevir and Pegasys®/Copegus® in Patients With Chronic Hepatitis C Genotype 1 Virus Infection Who Were Prior Null Responders to Treatment With Pegylated Interferon/Ribavirin', 'orgStudyIdInfo': {'id': 'NV27780'}, 'secondaryIdInfos': [{'id': '2011-002714-37', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Arm A', 'description': '24 weeks of therapy with mericitabine 1000 mg twice a day (BID), boceprevir 800 mg three times daily (TID), Pegasys 180 microgram/week, and Copegus 1000/1200 mg/day (total treatment duration of 24 weeks), followed by a 24-week treatment-free follow-up period.', 'interventionNames': ['Drug: Copegus', 'Drug: Pegasys', 'Drug: boceprevir', 'Drug: mericitabine']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Arm B', 'description': '24 weeks of therapy with mericitabine + boceprevir + Pegasys/Copegus followed by 24 weeks of therapy with boceprevir + Pegasys/Copegus (triple) (total treatment duration of 48 weeks), followed by a 24-week treatment-free follow-up period.', 'interventionNames': ['Drug: Copegus', 'Drug: Pegasys', 'Drug: boceprevir', 'Drug: mericitabine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment Arm C (Control)', 'description': '4 weeks of therapy with mericitabine placebo, boceprevir placebo + Pegasys/Copegus, then 20 weeks of therapy with mericitabine placebo + boceprevir + Pegasys/Copegus, then 24 weeks of therapy with boceprevir + Pegasys/Copegus (total treatment duration of 48 weeks), followed by a 24-week treatment-free follow-up period.', 'interventionNames': ['Drug: Copegus', 'Drug: Pegasys', 'Drug: mericitabine placebo', 'Drug: boceprevir placebo', 'Drug: boceprevir']}], 'interventions': [{'name': 'Copegus', 'type': 'DRUG', 'description': 'total daily dose of 1000 mg or 1200 mg for 24 weeks', 'armGroupLabels': ['Treatment Arm A']}, {'name': 'Copegus', 'type': 'DRUG', 'description': 'total daily dose of 1000 mg or 1200 mg for 48 weeks', 'armGroupLabels': ['Treatment Arm B', 'Treatment Arm C (Control)']}, {'name': 'Pegasys', 'type': 'DRUG', 'description': '180 microgram subcutaneous once a week for 24 weeks', 'armGroupLabels': ['Treatment Arm A']}, {'name': 'Pegasys', 'type': 'DRUG', 'description': '180 microgram subcutaneous once a week for 48 weeks', 'armGroupLabels': ['Treatment Arm B', 'Treatment Arm C (Control)']}, {'name': 'boceprevir', 'type': 'DRUG', 'description': '800 mg three times a day for 24 weeks', 'armGroupLabels': ['Treatment Arm A']}, {'name': 'boceprevir', 'type': 'DRUG', 'description': '800 mg three times a day for 48 weeks', 'armGroupLabels': ['Treatment Arm B']}, {'name': 'mericitabine', 'type': 'DRUG', 'description': '1000 mg twice daily for 24 weeks', 'armGroupLabels': ['Treatment Arm A', 'Treatment Arm B']}, {'name': 'mericitabine placebo', 'type': 'DRUG', 'description': 'mericitabine placebo', 'armGroupLabels': ['Treatment Arm C (Control)']}, {'name': 'boceprevir placebo', 'type': 'DRUG', 'description': 'boceprevir placebo', 'armGroupLabels': ['Treatment Arm C (Control)']}, {'name': 'boceprevir', 'type': 'DRUG', 'description': '800 mg three times a day for 44 weeks', 'armGroupLabels': ['Treatment Arm C (Control)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80120', 'city': 'Littleton', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.61332, 'lon': -105.01665}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '71130', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '64128', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23320-1706', 'city': 'Chesapeake', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 36.81904, 'lon': -76.27494}}, {'zip': 'T2N 4Z6', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'V5Z 1H2', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '06202', 'city': 'Nice', 'country': 'France', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '20099', 'city': 'Hamburg', 'country': 'Germany', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '80131', 'city': 'Napoli', 'state': 'Campania', 'country': 'Italy', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '20121', 'city': 'Milan', 'state': 'Lombardy', 'country': 'Italy', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '50134', 'city': 'Florence', 'state': 'Tuscany', 'country': 'Italy', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '00716', 'city': 'Ponce', 'country': 'Puerto Rico', 'geoPoint': {'lat': 18.01031, 'lon': -66.62398}}, {'zip': '07010', 'city': 'Palma de Mallorca', 'state': 'Balearic Islands', 'country': 'Spain', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '39008', 'city': 'Santander', 'state': 'Cantabria', 'country': 'Spain', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '36071', 'city': 'Pontevedra', 'state': 'Pontevedra', 'country': 'Spain', 'geoPoint': {'lat': 42.431, 'lon': -8.64435}}, {'zip': '46014', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}