Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-01-07 @ 11:59 AM
Study NCT ID:
NCT01356160
Status:
COMPLETED
Last Update Posted:
2014-02-03
First Post:
2011-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GS-5885 Alone or in Combination With GS-9451 With Peginterferon Alfa 2a and Ribavirin in Treatment Chronic Genotype 1 Hepatitis C Virus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'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': 'C586541', 'term': 'ledipasvir'}, {'id': 'C573362', 'term': 'GS-9451'}, {'id': 'C100416', 'term': 'peginterferon alfa-2a'}, {'id': 'D012254', 'term': 'Ribavirin'}], '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': 351}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'dispFirstSubmitDate': '2013-11-26', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-02', 'studyFirstSubmitDate': '2011-05-02', 'dispFirstSubmitQcDate': '2013-11-26', 'studyFirstSubmitQcDate': '2011-05-18', 'dispFirstPostDateStruct': {'date': '2013-12-20', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the antiviral efficacy of response guided therapy.', 'timeFrame': 'Through 24 weeks post-treatment', 'description': 'To evaluate the antiviral efficacy as measured by sustained virologic response (SVR, defined as plasma HCV RNA \\< Lower Limit of Quantification (LLoQ) at 24 weeks post-treatment) of response guided therapy (RGT) with GS-5885 + GS-9451 + PEG/RBV, or GS-5885 + PEG/RBV.'}], 'secondaryOutcomes': [{'measure': 'To evaluate the safety and tolerability of each regimen.', 'timeFrame': 'Through 24 weeks post-treatment', 'description': 'The primary safety endpoint is any AE leading to permanent discontinuation of study drugs.'}, {'measure': 'To characterize viral dynamics of GS-5885 and GS-9451 when administered with PEG and RBV.', 'timeFrame': 'Through Day 10 on study', 'description': 'HCV RNA levels, pharmacokinetics and viral sequencing'}, {'measure': 'To characterize the viral resistance to GS-5885 and GS-9451 when administered in combination with PEG and RBV.', 'timeFrame': '12 or 24 weeks', 'description': 'Plasma samples will be collected and stored at each visit for possible resistance analysis.'}, {'measure': 'To characterize steady state pharmacokinetics of GS-5885 and GS-9451 when administered with PEG and RBV.', 'timeFrame': 'Through 48 weeks of treatment', 'description': 'Plasma concentrations of the study drug over time will be summarized using descriptive statistics.'}]}, 'conditionsModule': {'keywords': ['Hepatitis C', 'HCV', 'Rapid Virologic Response', 'Sustained Virologic Response', 'Direct Acting Antiviral', 'Combination Therapy HCV RNA', 'Protease inhibitor', 'Treatment naïve', 'GS-5885', 'GS-9451'], 'conditions': ['Hepatitis C, Chronic']}, 'descriptionModule': {'briefSummary': 'This is a Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy with GS-5885 Alone or in Combination with GS-9451 with Peginterferon Alfa 2a and Ribavirin in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females 18-70 years of age\n* Chronic HCV infection\n* Subjects must have liver biopsy results (≤ 2 years prior to Screening) indicating the absence of cirrhosis.\n* Monoinfection with HCV genotype 1\n* HCV RNA \\> 10\\^4 IU/mL at Screening\n* HCV treatment naïve\n* Candidate for PEG/RBV therapy\n* Body mass index (BMI) 18-36 kg/m2, inclusive\n* Agree to use two forms of highly effective contraception methods for the duration of the study and for 7 months after the last dose of study medication. Females of childbearing potential must have negative pregnancy test at Screening and Baseline.\n\nExclusion Criteria:\n\n* Pregnant female or male with pregnant female partner\n* Exceed defined thresholds for leukopenia, neutropenia, anemia, thrombocytopenia, thyroid stimulating hormone (TSH)\n* Diagnosis of autoimmune disease, decompensated liver disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease (COPD), HIV, hepatitis B virus (HBV), hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers), hemoglobinopathy, retinal disease, or are immunosuppressed.\n* Subjects with current use of amphetamines, cocaine, opiates (e.g., morphine, heroin), or ongoing alcohol abuse are excluded. Patients on stable methadone or buprenorphine maintenance treatment for at least 6 months prior to Screening may be included into the study.'}, 'identificationModule': {'nctId': 'NCT01356160', 'briefTitle': 'GS-5885 Alone or in Combination With GS-9451 With Peginterferon Alfa 2a and Ribavirin in Treatment Chronic Genotype 1 Hepatitis C Virus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy With GS-5885 Alone or in Combination With GS-9451 With Peginterferon Alfa 2a and Ribavirin in Treatment Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection', 'orgStudyIdInfo': {'id': 'GS-US-256-0148'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1', 'description': 'RGT with GS-5885 30 mg QD + GS-9451 200 mg QD + PEG/RBV', 'interventionNames': ['Drug: GS-5885', 'Drug: GS-9451', 'Biological: peginterferon alfa-2a', 'Drug: ribavirin tablet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 2', 'description': 'RGT with GS-5885 30 mg QD + GS-9451 placebo QD + PEG/RBV', 'interventionNames': ['Drug: GS-5885', 'Biological: peginterferon alfa-2a', 'Drug: ribavirin tablet', 'Drug: GS-9451 Placebo']}], 'interventions': [{'name': 'GS-5885', 'type': 'DRUG', 'description': 'tablet, 30 mg QD', 'armGroupLabels': ['Arm 1', 'Arm 2']}, {'name': 'GS-9451', 'type': 'DRUG', 'description': 'tablet, 200 mg QD', 'armGroupLabels': ['Arm 1']}, {'name': 'peginterferon alfa-2a', 'type': 'BIOLOGICAL', 'description': '(solution for injection) 180 µg/week', 'armGroupLabels': ['Arm 1', 'Arm 2']}, {'name': 'ribavirin tablet', 'type': 'DRUG', 'description': 'ribavirin tablet (weight based: 1000 mg/day \\<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)', 'armGroupLabels': ['Arm 1', 'Arm 2']}, {'name': 'GS-9451 Placebo', 'type': 'DRUG', 'description': 'Placebo to match GS-9451 QD', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92118', 'city': 'Coronado', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.68589, 'lon': -117.18309}}, {'zip': '92626', 'city': 'Costa Mesa', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.64113, 'lon': -117.91867}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80110', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '34209', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '21202', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21229', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '01805', 'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}, {'zip': '64131', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '11375', 'city': 'Forest Hills', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71621, 'lon': -73.85014}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '37211', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '76012', 'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}, {'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': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '4029', 'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '00927', 'city': 'San Juan', 'country': 'Puerto Rico', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Bittoo Kanwar, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Gilead Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}