Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-31 @ 4:08 PM
Study NCT ID:
NCT01628094
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2012-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ANNAPURNA: A Study of The Combination of RO5466731, RO5190591, Ritonavir and Copegus (Ribavirin) With or Without RO5024048 in Patients With Chronic Hepatitis C Who Are Either Treatment-Naïve or Have Previously Experienced a Null Response to Interferon-Based Treatment
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': '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': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'dispFirstSubmitDate': '2016-06-30', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2012-06-22', 'dispFirstSubmitQcDate': '2016-07-01', 'studyFirstSubmitQcDate': '2012-06-22', 'dispFirstPostDateStruct': {'date': '2016-07-04', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sustained virological response (defined as undetectable serum HCV RNA) 12 weeks after end of treatment', 'timeFrame': 'approximately 20 months'}, {'measure': 'Safety: Incidence of adverse events', 'timeFrame': 'approximately 20 months'}], 'secondaryOutcomes': [{'measure': 'Antiviral activity: Change in serum HCV RNA levels', 'timeFrame': 'from baseline to 24 weeks after end of treatment'}, {'measure': 'Pharmacokinetics in coadministration: Area under the concentration-time curve (AUC)', 'timeFrame': 'Pre-dose Weeks 1, 2, 3, 4, 6, 10, and 12 and up to 12 hours post-dose Weeks 1, and 4 or 3 and 6'}, {'measure': 'HCV drug resistance', 'timeFrame': 'approximately 20 months'}, {'measure': 'Quality of life: Short-Form 36v2/Brief Fatigue Inventory questionnaires', 'timeFrame': 'approximately 20 months'}]}, 'conditionsModule': {'conditions': ['Hepatitis C, Chronic']}, 'referencesModule': {'references': [{'pmid': '26519669', 'type': 'DERIVED', 'citation': 'Jensen DM, Brunda M, Elston R, Gane EJ, George J, Glavini K, Hammond JM, Le Pogam S, Najera I, Passe S, Piekarska A, Rodriguez I, Zeuzem S, Chu T; ANNAPURNA study investigators. Interferon-free regimens containing setrobuvir for patients with genotype 1 chronic hepatitis C: a randomized, multicenter study. Liver Int. 2016 Apr;36(4):505-14. doi: 10.1111/liv.12997. Epub 2015 Dec 12.'}]}, 'descriptionModule': {'briefSummary': 'This randomized, open-label, multicenter study will evaluate the safety , efficacy and tolerability of the combination treatment RO5466731, RO5190591, ritonavir and Copegus (ribavirin) with or without RO5024048 in patients with chronic hepatitis C genotype 1. In Part 1, treatment-naïve patients will be randomized to receive treatment with RO5466731, RO5190591 plus ritonavir, and Copegus, with or without RO5024048. In Part 2, further treatment-naïve patients will receive a successful regimen from Part 1, or a reduced intensity regimen, and patients who have previously experienced null response to interferon-based treatment will be added to the study.'}, '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 genotype 1 of \\>/= 6 months duration at screening\n* Part 1 and Part 2: Naïve to treatment with interferon (pegylated or non-pegylated). Patients who have participated in studies investigating a direct-acting antiviral agent with or without interferon are excluded\n* Part 2: Treatment experienced patients having a previous null response to treatment with interferon containing regimen\n* Liver biopsy or non-invasive (e.g. Fibroscan) evaluation in the past 24 calendar months showing absence of cirrhosis or incomplete/transition to cirrhosis\n* Body mass index (BMI) 18 to 35 kg/m2 inclusive and body weight \\>/= 45 kg\n\nExclusion Criteria:\n\n* Pregnant or lactating women or males with female partners who are pregnant or lactating\n* Decompensated liver disease or impaired liver function (as defined by protocol)\n* Cirrhosis or incomplete/transition to cirrhosis\n* Non- hepatitis C chronic liver disease\n* Positive for hepatitis B or HIV infection\n* History of pre-existing renal disease\n* History of severe cardiac disease\n* History of neoplastic disease within the last 5 years, except for localized or in situ carcinoma of the skin\n* History of drug abuse within the last year; history of cannabinoid use is not excluded\n* Evidence of alcohol abuse within 1 year of screening and consumption of more than 2 units of alcohol per day\n* Medical condition that requires use of systemic corticosteroids\n* Received warfarin or other anticoagulants during the 21 days immediately prior to screening or is expected to require warfarin or other anticoagulants during the study\n* Anticipated use or need for significant medical treatment during the study or use of concomitant medications or nutrients that are excluded by protocol (e.g. drugs that are contraindicated with ritonavir, hormonal methods of contraception)'}, 'identificationModule': {'nctId': 'NCT01628094', 'briefTitle': 'ANNAPURNA: A Study of The Combination of RO5466731, RO5190591, Ritonavir and Copegus (Ribavirin) With or Without RO5024048 in Patients With Chronic Hepatitis C Who Are Either Treatment-Naïve or Have Previously Experienced a Null Response to Interferon-Based Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Randomized, Open-Label, Multicenter Study of Safety, Efficacy, and Tolerability of the Combination of RO5466731, RO5190591, Ritonavir, and Copegus With or Without RO5024048 in HCV Genotype 1 Infected Patients Who Are Either Treatment Naïve or Null Responders to Previous Interferon-Based Treatment', 'orgStudyIdInfo': {'id': 'NP28266'}, 'secondaryIdInfos': [{'id': '2012-000638-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A: GT1a 3DAA', 'description': 'including RO5466731, RO5190591, ritonavir, ribavirin \\[Copegus\\] and RO5024048', 'interventionNames': ['Drug: RO5024048', 'Drug: RO5190591', 'Drug: RO5466731', 'Drug: ribavirin [Copegus]', 'Drug: ritonavir']}, {'type': 'EXPERIMENTAL', 'label': 'B: GT1a 3DAA', 'description': 'including RO5466731, RO5190591, ritonavir, ribavirin \\[Copegus\\] and RO5024048', 'interventionNames': ['Drug: RO5024048', 'Drug: RO5190591', 'Drug: RO5466731', 'Drug: ribavirin [Copegus]', 'Drug: ritonavir']}, {'type': 'EXPERIMENTAL', 'label': 'C: GT1a 2DAA', 'description': 'including RO5466731, RO5190591, ritonavir and ribavirin \\[Copegus\\]', 'interventionNames': ['Drug: RO5190591', 'Drug: RO5466731', 'Drug: ribavirin [Copegus]', 'Drug: ritonavir']}, {'type': 'EXPERIMENTAL', 'label': 'D: GT1b 3DAA', 'description': 'including RO5466731, RO5190591, ritonavir, ribavirin \\[Copegus\\] and RO5024048', 'interventionNames': ['Drug: RO5024048', 'Drug: RO5190591', 'Drug: RO5466731', 'Drug: ribavirin [Copegus]', 'Drug: ritonavir']}, {'type': 'EXPERIMENTAL', 'label': 'E: GT1b 2DAA', 'description': 'including RO54664731, RO5190591, ritonavir and ribavirin \\[Copegus\\]', 'interventionNames': ['Drug: RO5190591', 'Drug: RO5466731', 'Drug: ribavirin [Copegus]', 'Drug: ritonavir']}, {'type': 'EXPERIMENTAL', 'label': 'Part II', 'interventionNames': ['Drug: RO5024048', 'Drug: RO5190591', 'Drug: RO5466731', 'Drug: ribavirin [Copegus]', 'Drug: ritonavir']}], 'interventions': [{'name': 'RO5024048', 'type': 'DRUG', 'armGroupLabels': ['A: GT1a 3DAA', 'B: GT1a 3DAA', 'D: GT1b 3DAA', 'Part II']}, {'name': 'RO5190591', 'type': 'DRUG', 'armGroupLabels': ['A: GT1a 3DAA', 'B: GT1a 3DAA', 'C: GT1a 2DAA', 'D: GT1b 3DAA', 'E: GT1b 2DAA', 'Part II']}, {'name': 'RO5466731', 'type': 'DRUG', 'armGroupLabels': ['A: GT1a 3DAA', 'B: GT1a 3DAA', 'C: GT1a 2DAA', 'D: GT1b 3DAA', 'E: GT1b 2DAA', 'Part II']}, {'name': 'ribavirin [Copegus]', 'type': 'DRUG', 'armGroupLabels': ['A: GT1a 3DAA', 'B: GT1a 3DAA', 'C: GT1a 2DAA', 'D: GT1b 3DAA', 'E: GT1b 2DAA', 'Part II']}, {'name': 'ritonavir', 'type': 'DRUG', 'armGroupLabels': ['A: GT1a 3DAA', 'B: GT1a 3DAA', 'C: GT1a 2DAA', 'D: GT1b 3DAA', 'E: GT1b 2DAA', 'Part II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '63104', 'city': 'Saint Louise', 'state': 'Missouri', 'country': 'United States'}, {'zip': '28801', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78234', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98664', 'city': 'Vancouver', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 45.63873, 'lon': -122.66149}}, {'city': 'Kingswood', 'state': 'New South Wales', 'country': 'Australia', 'geoPoint': {'lat': -33.75614, 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'9016', 'city': 'Dunedin', 'country': 'New Zealand', 'geoPoint': {'lat': -45.87416, 'lon': 170.50361}}, {'zip': '1010', 'city': 'Grafton', 'country': 'New Zealand', 'geoPoint': {'lat': -36.86029, 'lon': 174.76566}}, {'city': 'Hamilton', 'country': 'New Zealand', 'geoPoint': {'lat': -37.78333, 'lon': 175.28333}}, {'zip': '15-540', 'city': 'Bialystok', 'country': 'Poland', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '41-500', 'city': 'Chorzów', 'country': 'Poland', 'geoPoint': {'lat': 50.30582, 'lon': 18.9742}}, {'zip': '91-357', 'city': 'Lodz', 'country': 'Poland', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '41-400', 'city': 'Mysłowice', 'country': 'Poland', 'geoPoint': {'lat': 50.20745, 'lon': 19.16668}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}