Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-28 @ 8:50 AM
Study NCT ID:
NCT01749150
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2012-12-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Ritonavir-Boosted Danoprevir in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients of Asian Origin With Chronic Hepatitis C Genotype 1 With or Without Cirrhosis
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': 'C553752', 'term': 'danoprevir'}, {'id': 'D019438', 'term': 'Ritonavir'}, {'id': 'C100416', 'term': 'peginterferon alfa-2a'}, {'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'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'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2012-12-11', 'studyFirstSubmitQcDate': '2012-12-11', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety: Incidence of adverse events', 'timeFrame': 'approximately 1.5 years'}, {'measure': 'Pharmacokinetics: Area under the concentration-time curve (AUC) for danoprevir/ritonavir', 'timeFrame': 'up to 14 days'}, {'measure': 'Antiviral activity: Change in HCV RNA levels, measured using Roche COBAS TaqMan HCV Test v2.0 for High Pure System', 'timeFrame': 'from baseline to Week 36/48'}, {'measure': 'Antiviral activity: Proportion of patients with unquantifiable/undetectable HCV RNA during the study', 'timeFrame': 'approximately 1.5 years'}], 'secondaryOutcomes': [{'measure': 'Incidence of viral resistance to danoprevir', 'timeFrame': 'approximately 1.5 years'}, {'measure': 'Rapid virological response (RVR): Proportion of patients with undetectable HCV RNA at Week 4', 'timeFrame': 'approximately 1.5 years'}, {'measure': 'Complete early virological response (cEVR): Proportion of patients with undetectable HCV RNA at Week 12', 'timeFrame': 'approximately 1.5 years'}, {'measure': 'Sustained virological response 12 weeks after end of treatment (SVR-12), defined as unquantifiable HCV RNA 8-20 weeks after the last day of study drug administration', 'timeFrame': 'approximately 1.5 years'}, {'measure': 'Sustained virological response 24 weeks after end of treatment (SVR-24), defined as unquantifiable HCV RNA > 20 weeks after the last day of study drug administration', 'timeFrame': 'approximately 1.5 years'}, {'measure': 'SVR measured as HCV RNA log10 IU/mL change from baseline to Week 12', 'timeFrame': 'approximately 1.5 years'}]}, 'conditionsModule': {'conditions': ['Hepatitis C, Chronic']}, 'descriptionModule': {'briefSummary': 'This Phase II, open-label, parallel-arm study will evaluate the safety, tolerability, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in treatment-naïve patients of Asian origin with chronic hepatitis C genotype 1. Patients will receive danoprevir 125 mg plus ritonavir 100 mg as fixed dose tablet orally twice daily in combination with weekly Pegasys 180 mcg subcutaneously and Copegus 1000-1200 mg orally daily in divided doses. Treatment duration is 12 weeks in patients without cirrhosis and 24 weeks in patients with compensated cirrhosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients of East Asian or Southeast Asian origin, \\>/= 18 years of age\n* Presence of chronic genotype 1 hepatitis C infection\n* Treatment-naïve\n\nExclusion Criteria:\n\n* History or presence of decompensated liver disease\n* Presence or history of non-hepatitis C chronic liver disease\n* Positive for hepatitis B or HIV infection'}, 'identificationModule': {'nctId': 'NCT01749150', 'briefTitle': 'A Study of Ritonavir-Boosted Danoprevir in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients of Asian Origin With Chronic Hepatitis C Genotype 1 With or Without Cirrhosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTIVIRAL ACTIVITY OF RITONAVIR-BOOSTED DANOPREVIR IN COMBINATION WITH PEGINTERFERON ALFA-2A PLUS RIBAVIRIN IN TREATMENT-NAÏVE PATIENTS OF ASIAN ORIGIN WHO HAVE CHRONIC HEPATITIS C GENOTYPE 1 WITH OR WITHOUT COMPENSATED CIRRHOSIS', 'orgStudyIdInfo': {'id': 'YV28218'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'with cirrhosis', 'interventionNames': ['Drug: danoprevir + ritonavir', 'Drug: peginterferon alfa-2a [Pegasys]', 'Drug: ribavirin [Copegus]']}, {'type': 'EXPERIMENTAL', 'label': 'without cirrhosis', 'interventionNames': ['Drug: danoprevir + ritonavir', 'Drug: peginterferon alfa-2a [Pegasys]', 'Drug: ribavirin [Copegus]']}], 'interventions': [{'name': 'danoprevir + ritonavir', 'type': 'DRUG', 'description': '125 mg danoprevir + 100 mg ritonvir fixed-dose combination tablet, orally b.i.d., 12 weeks', 'armGroupLabels': ['without cirrhosis']}, {'name': 'danoprevir + ritonavir', 'type': 'DRUG', 'description': '125 mg danoprevir + 100 mg ritonvir fixed-dose combination tablet, orally b.i.d., 24 weeks', 'armGroupLabels': ['with cirrhosis']}, {'name': 'peginterferon alfa-2a [Pegasys]', 'type': 'DRUG', 'description': '180 mcg sc weekly, 12 weeks', 'armGroupLabels': ['without cirrhosis']}, {'name': 'peginterferon alfa-2a [Pegasys]', 'type': 'DRUG', 'description': '180 mcg sc weekly, 24 weeks', 'armGroupLabels': ['with cirrhosis']}, {'name': 'ribavirin [Copegus]', 'type': 'DRUG', 'description': '1000-1200 mg orally daily in divided doses, 12 weeks', 'armGroupLabels': ['without cirrhosis']}, {'name': 'ribavirin [Copegus]', 'type': 'DRUG', 'description': '1000-1200 mg orally daily in divided doses, 24 weeks', 'armGroupLabels': ['with cirrhosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '614-735', 'city': 'Busan', 'country': 'South Korea', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '61363', 'city': 'Chiayi County', 'country': 'Taiwan'}, {'zip': '807', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '40447', 'city': 'Taichung', 'country': 'Taiwan', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '333', 'city': 'Taoyuan District', 'country': 'Taiwan', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}, {'zip': '640', 'city': 'Yunlin County', 'country': 'Taiwan'}, {'zip': '10330', 'city': 'Bangkok', 'country': 'Thailand', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '50200', 'city': 'Chiang Mai', 'country': 'Thailand', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}