GS-5885 Alone or in Combination With GS-9451 With Peginterferon Alfa 2a and Ribavirin in Treatment Chronic Genotype 1 Hepatitis C Virus
NCT ID: NCT01356160
Last Updated: 2014-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
351 participants
INTERVENTIONAL
2011-07-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1
RGT with GS-5885 30 mg QD + GS-9451 200 mg QD + PEG/RBV
GS-5885
tablet, 30 mg QD
GS-9451
tablet, 200 mg QD
peginterferon alfa-2a
(solution for injection) 180 µg/week
ribavirin tablet
ribavirin tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
Arm 2
RGT with GS-5885 30 mg QD + GS-9451 placebo QD + PEG/RBV
GS-5885
tablet, 30 mg QD
peginterferon alfa-2a
(solution for injection) 180 µg/week
ribavirin tablet
ribavirin tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
GS-9451 Placebo
Placebo to match GS-9451 QD
Interventions
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GS-5885
tablet, 30 mg QD
GS-9451
tablet, 200 mg QD
peginterferon alfa-2a
(solution for injection) 180 µg/week
ribavirin tablet
ribavirin tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
GS-9451 Placebo
Placebo to match GS-9451 QD
Eligibility Criteria
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Inclusion Criteria
* Chronic HCV infection
* Subjects must have liver biopsy results (≤ 2 years prior to Screening) indicating the absence of cirrhosis.
* Monoinfection with HCV genotype 1
* HCV RNA \> 10\^4 IU/mL at Screening
* HCV treatment naïve
* Candidate for PEG/RBV therapy
* Body mass index (BMI) 18-36 kg/m2, inclusive
* 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.
Exclusion Criteria
* Exceed defined thresholds for leukopenia, neutropenia, anemia, thrombocytopenia, thyroid stimulating hormone (TSH)
* 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.
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Bittoo Kanwar, MD
Role: STUDY_CHAIR
Gilead Sciences
Locations
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Tucson, Arizona, United States
Beverly Hills, California, United States
Coronado, California, United States
Costa Mesa, California, United States
San Diego, California, United States
Aurora, Colorado, United States
Englewood, Colorado, United States
Bradenton, Florida, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Burlington, Massachusetts, United States
Kansas City, Missouri, United States
Forest Hills, New York, United States
Manhasset, New York, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Nashville, Tennessee, United States
Arlington, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Fairfax, Virginia, United States
Herston, Queensland, Australia
San Juan, , Puerto Rico
Countries
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Other Identifiers
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GS-US-256-0148
Identifier Type: -
Identifier Source: org_study_id
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