Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2025-12-29 @ 7:09 AM
Study NCT ID:
NCT01331850
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2011-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Danoprevir/Ritonavir and Copegus With RO5024048 and/or Pegasys 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': 'C553752', 'term': 'danoprevir'}, {'id': 'D019438', 'term': 'Ritonavir'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 381}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'dispFirstSubmitDate': '2016-07-08', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2011-03-28', 'dispFirstSubmitQcDate': '2016-07-08', 'studyFirstSubmitQcDate': '2011-04-07', 'dispFirstPostDateStruct': {'date': '2016-07-12', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sustained virological response (SVR) of danoprevir/ritonavir with RO5024048 and Copegus in patients with previous partial or null response to peginterferon/ribavirin treatment', 'timeFrame': '24 weeks'}, {'measure': 'Sustained virological response (SVR) of danoprevir/ritonavir with Pegasys and Copegus in patients with previous partial response to peginterferon/ribavirin treatment', 'timeFrame': '24 weeks'}, {'measure': 'Sustained virological response (SVR) of danoprevir/ritonavir and RO5024048 with Pegasys and Copegus in patients with previous partial or null response to peginterferon/ribavirin treatment', 'timeFrame': '24 weeks'}, {'measure': 'Sustained virological response (SVR) of danoprevir/ritonavir and RO5024048 with Pegasys and Copegus followed by 24 weeks of Pegasys and Copegus treatment in patients with previous null response to peginterferon/ribavirin treatment', 'timeFrame': '48 weeks'}], 'secondaryOutcomes': [{'measure': 'Safety (Incidence of adverse events) of danoprevir, RO5024048 and Copegus', 'timeFrame': '48 weeks'}, {'measure': 'Safety (Incidence of adverse events) of danoprevir, Pegasys and Copegus', 'timeFrame': '48 weeks'}, {'measure': 'Safety (Incidence of adverse events) of danoprevir, RO5024048, Pegasys and Copegus', 'timeFrame': '72 weeks'}, {'measure': 'Virological response over time', 'timeFrame': '48 weeks'}, {'measure': 'Change in danoprevir plasma concentration', 'timeFrame': '24 weeks'}, {'measure': 'Change in RO5024048 plasma concentration', 'timeFrame': '24 weeks'}, {'measure': 'Hepatitis C virus drug resistance profile', 'timeFrame': '24 weeks'}]}, 'conditionsModule': {'conditions': ['Hepatitis C, Chronic']}, 'descriptionModule': {'briefSummary': 'This randomized, open-label, multi-center study will evaluate the sustained virological response, pharmacokinetics and safety of various combinations of danoprevir/ritonavir with Copegus plus RO5024048 and/or Pegasys in patients with chronic hepatitis C infection. Patients will be divided into 2 separate cohorts. Cohort A, previous partial responders, will be randomized to Groups 1-3 and cohort B, previous null responders, will be randomized to Groups 4-6. Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Groups 1 and 4 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Group 2 will receive Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Groups 3, 5 and 6 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. In addition, patients in Group 6 will receive another 24 weeks of Pegasys plus Copegus treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, age 18 years and older\n* Presence of hepatitis C infection, genotype 1a or 1b\n* Documentation of previous treatment failure after receiving approved doses of peginterferon plus ribavirin for at least 12 weeks\n* Patients must have discontinued prior hepatitis C treatment at least 12 weeks prior to study start\n\nExclusion Criteria:\n\n* Infection with any hepatitis C genotype or subtype other than genotype 1a or 1b\n* Patients with cirrhosis\n* Patients who were discontinued from previous peginterferon plus ribavirin therapy due to reasons other than insufficient therapeutic response\n* Co-infection with hepatitis B or human immunodeficiency virus (HIV)\n* History or evidence of chronic liver disease other than hepatitis C'}, 'identificationModule': {'nctId': 'NCT01331850', 'briefTitle': 'A Study of Danoprevir/Ritonavir and Copegus With RO5024048 and/or Pegasys in Patients With Chronic Hepatitis C', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Randomized Open-label Study to Evaluate the Sustained Virologic Response of Danoprevir/Ritonavir and Copegus in Combination With RO5024048 and/or Pegasys in Chronic Hepatitis C Genotype 1 Patients Who Failed Previous Standard Therapy', 'orgStudyIdInfo': {'id': 'WV21913'}, 'secondaryIdInfos': [{'id': '2010-019585-90'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Previous null responders (Cohort B): Group 4', 'description': 'Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Group 4 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks.', 'interventionNames': ['Drug: Copegus', 'Drug: RO5024048', 'Drug: danoprevir', 'Drug: ritonavir']}, {'type': 'EXPERIMENTAL', 'label': 'Previous null responders (Cohort B): Group 5', 'description': 'Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. Group 5 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks.', 'interventionNames': ['Drug: Copegus', 'Drug: Pegasys', 'Drug: RO5024048', 'Drug: danoprevir', 'Drug: ritonavir']}, {'type': 'EXPERIMENTAL', 'label': 'Previous null responders (Cohort B): Group 6', 'description': 'Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. Group 6 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. In addition, patients in Group 6 will receive another 24 weeks of Pegasys plus Copegus treatment.', 'interventionNames': ['Drug: Copegus', 'Drug: Pegasys', 'Drug: RO5024048', 'Drug: danoprevir', 'Drug: ritonavir']}, {'type': 'EXPERIMENTAL', 'label': 'Previous partial responders (Cohort A): Group 1', 'description': 'Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Group 1 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks.', 'interventionNames': ['Drug: Copegus', 'Drug: RO5024048', 'Drug: danoprevir', 'Drug: ritonavir']}, {'type': 'EXPERIMENTAL', 'label': 'Previous partial responders (Cohort A): Group 2', 'description': 'Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Group 2 will receive Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks.', 'interventionNames': ['Drug: Copegus', 'Drug: Pegasys', 'Drug: danoprevir', 'Drug: ritonavir']}, {'type': 'EXPERIMENTAL', 'label': 'Previous partial responders (Cohort A): Group 3', 'description': 'Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. Group 3 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks.', 'interventionNames': ['Drug: Copegus', 'Drug: Pegasys', 'Drug: RO5024048', 'Drug: danoprevir', 'Drug: ritonavir']}], 'interventions': [{'name': 'Copegus', 'type': 'DRUG', 'description': '1000 mg or 1200 mg daily oral doses for 24 weeks', 'armGroupLabels': ['Previous null responders (Cohort B): Group 4', 'Previous null responders (Cohort B): Group 5', 'Previous partial responders (Cohort A): Group 1', 'Previous partial responders (Cohort A): Group 2', 'Previous partial responders (Cohort A): Group 3']}, {'name': 'Copegus', 'type': 'DRUG', 'description': '1000 mg or 1200 mg daily oral doses for 48 weeks', 'armGroupLabels': ['Previous null responders (Cohort B): Group 6']}, {'name': 'Pegasys', 'type': 'DRUG', 'description': '180 microgram subcutaneously once weekly for 24 weeks', 'armGroupLabels': ['Previous null responders (Cohort B): Group 5', 'Previous partial responders (Cohort A): Group 2', 'Previous partial responders (Cohort A): Group 3']}, {'name': 'Pegasys', 'type': 'DRUG', 'description': '180 microgram subcutaneously once weekly for 48 weeks', 'armGroupLabels': ['Previous null responders (Cohort B): Group 6']}, {'name': 'RO5024048', 'type': 'DRUG', 'description': '1000 mg oral doses twice a day for 24 weeks', 'armGroupLabels': ['Previous null responders (Cohort B): Group 4', 'Previous null responders (Cohort B): Group 5', 'Previous null responders (Cohort B): Group 6', 'Previous partial responders (Cohort A): Group 1', 'Previous partial responders (Cohort A): Group 3']}, {'name': 'danoprevir', 'type': 'DRUG', 'description': '100 mg oral doses twice a day for 24 weeks', 'armGroupLabels': ['Previous null responders (Cohort B): Group 4', 'Previous null responders (Cohort B): Group 5', 'Previous null responders (Cohort B): Group 6', 'Previous partial responders (Cohort A): Group 1', 'Previous partial responders (Cohort A): Group 2', 'Previous partial responders (Cohort A): Group 3']}, {'name': 'ritonavir', 'type': 'DRUG', 'description': '100 mg oral doses twice a day for 24 weeks', 'armGroupLabels': ['Previous null responders (Cohort B): Group 4', 'Previous null responders (Cohort B): Group 5', 'Previous null responders (Cohort B): Group 6', 'Previous partial responders (Cohort A): Group 1', 'Previous partial responders (Cohort A): Group 2', 'Previous partial responders (Cohort A): Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037-1030', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90822', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92103', 'city': 'San 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'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}