Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2026-01-15 @ 3:23 PM
Study NCT ID:
NCT01185860
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2010-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Ritonavir-Boosted Danoprevir (RO5190591) in Combination With Pegasys and Ribavirin in Patients With Chronic Hepatitis C Genotype 1
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': 'C100416', 'term': 'peginterferon alfa-2a'}, {'id': 'D012254', 'term': 'Ribavirin'}, {'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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2010-08-19', 'studyFirstSubmitQcDate': '2010-08-19', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability: Adverse events, ECG, laboratory parameters', 'timeFrame': 'approximately 3 years'}, {'measure': 'Pharmacokinetics: Cmax, AUC, Cmin, Tmax, Cl, T1/2', 'timeFrame': 'Days 3-9'}, {'measure': 'Antiviral activity: HCV RNA (COBAS Taqman HCV Test)', 'timeFrame': 'from baseline to Day 28'}], 'secondaryOutcomes': [{'measure': 'Viral resistance development', 'timeFrame': 'from baseline to Day 17'}, {'measure': 'Effects on cytochrome P450(CYP)2C9 and 3A isozymes', 'timeFrame': 'from baseline to Day 17'}, {'measure': 'Virological response in prior null-responders', 'timeFrame': 'from baseline to week 72'}, {'measure': 'Comparison of pharmacokinetics and antiviral activity between treatment-naïve patients and prior null-responders to standard of care treatment', 'timeFrame': 'approximately 3 years'}]}, 'conditionsModule': {'conditions': ['Hepatitis C, Chronic']}, 'referencesModule': {'references': [{'pmid': '24295986', 'type': 'DERIVED', 'citation': 'Gane EJ, Rouzier R, Wiercinska-Drapalo A, Larrey DG, Morcos PN, Brennan BJ, Le Pogam S, Najera I, Petric R, Tran JQ, Kulkarni R, Zhang Y, Smith P, Yetzer ES, Shulman NS. Efficacy and safety of danoprevir-ritonavir plus peginterferon alfa-2a-ribavirin in hepatitis C virus genotype 1 prior null responders. Antimicrob Agents Chemother. 2014;58(2):1136-45. doi: 10.1128/AAC.01515-13. Epub 2013 Dec 2.'}, {'pmid': '23872824', 'type': 'DERIVED', 'citation': 'Morcos PN, Chang L, Kulkarni R, Giraudon M, Shulman N, Brennan BJ, Smith PF, Tran JQ. A randomised study of the effect of danoprevir/ritonavir or ritonavir on substrates of cytochrome P450 (CYP) 3A and 2C9 in chronic hepatitis C patients using a drug cocktail. Eur J Clin Pharmacol. 2013 Nov;69(11):1939-49. doi: 10.1007/s00228-013-1556-y. Epub 2013 Jul 20.'}, {'pmid': '21354234', 'type': 'DERIVED', 'citation': 'Gane EJ, Rouzier R, Stedman C, Wiercinska-Drapalo A, Horban A, Chang L, Zhang Y, Sampeur P, Najera I, Smith P, Shulman NS, Tran JQ. Antiviral activity, safety, and pharmacokinetics of danoprevir/ritonavir plus PEG-IFN alpha-2a/RBV in hepatitis C patients. J Hepatol. 2011 Nov;55(5):972-9. doi: 10.1016/j.jhep.2011.01.046. Epub 2011 Feb 24.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy, safety and tolerability of danoprevir (RO5190591) plus ritonavir as compared to danoprevir alone or placebo plus ritonavir in patients with chronic hepatitis C genotype 1 receiving Pegasys (peginterferon alfa-2a) and ribavirin. Patients in cohorts will be randomized to receive either oral doses of danoprevir, or danoprevir plus ritonavir, or placebo plus ritonavir. All patients will receive Pegasys (180mcg sc once weekly) plus ribavirin (1000-1200mg/day po), with the option to continue this treatment after completion of study drug treatment. Anticipated time on study treatment is up to 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults, 18-65 years of age\n* Chronic hepatitis C genotype 1\n* HCV treatment naïve, or without sustained virologic response on prior PEG-INF/RBV treatment\n* Body mass index (BMI) 18 - 35 kg/m2, inclusive; minimum weight 45 kg\n\nExclusion Criteria:\n\n* Liver cirrhosis\n* Decompensated liver disease or impaired liver function\n* Medical condition associated with chronic liver disease other than chronic hepatitis C\n* Positive for hepatitis B or HIV infection at screening\n* History of alcohol consumption exceeding 2 standard drinks per day when averaged over the course of a given week'}, 'identificationModule': {'nctId': 'NCT01185860', 'briefTitle': 'A Study of Ritonavir-Boosted Danoprevir (RO5190591) in Combination With Pegasys and Ribavirin in Patients With Chronic Hepatitis C Genotype 1', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Multiple-Dose Study To Evaluate Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Ritonavir-Boosted RO5190591 in Combination With Peginterferon Alfa-2a Plus Ribavirin in Patients With Chronic Hepatitis C Genotype 1', 'orgStudyIdInfo': {'id': 'NP22660'}, 'secondaryIdInfos': [{'id': '2009-012426-36'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'interventionNames': ['Drug: danoprevir', 'Drug: peginterferon alfa-2a [Pegasys]', 'Drug: ribavirin']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'interventionNames': ['Drug: danoprevir', 'Drug: peginterferon alfa-2a [Pegasys]', 'Drug: ribavirin', 'Drug: ritonavir']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'C', 'interventionNames': ['Drug: peginterferon alfa-2a [Pegasys]', 'Drug: placebo', 'Drug: ribavirin', 'Drug: ritonavir']}], 'interventions': [{'name': 'danoprevir', 'type': 'DRUG', 'description': 'oral doses', 'armGroupLabels': ['A', 'B']}, {'name': 'peginterferon alfa-2a [Pegasys]', 'type': 'DRUG', 'description': '180 mcg sc once weekly', 'armGroupLabels': ['A', 'B', 'C']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'oral doses', 'armGroupLabels': ['C']}, {'name': 'ribavirin', 'type': 'DRUG', 'description': '1000-1200mg/day po', 'armGroupLabels': ['A', 'B', 'C']}, {'name': 'ritonavir', 'type': 'DRUG', 'description': 'oral doses', 'armGroupLabels': ['B', 'C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34094', 'city': 'Montpellier', 'country': 'France', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '8011', 'city': 'Christchurch', 'country': 'New Zealand', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'zip': '1010', 'city': 'Grafton', 'country': 'New Zealand', 'geoPoint': {'lat': -36.86029, 'lon': 174.76566}}, {'zip': '01-201', 'city': 'Warsaw', 'country': 'Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}