Status:
COMPLETED
GS-5885, GS-9451, Tegobuvir and Ribovirin in Treatment-Experienced Subjects With Chronic Genotype 1a Or 1b Hepatitis C Virus (HCV) Infection
Lead Sponsor:
Gilead Sciences
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) Compared with GS-5885, GS-9451 with Tegobuvir or RBV in Treatment-Experienced Su...
Eligibility Criteria
Inclusion
- Age ≥18 years with chronic HCV infection
- Liver biopsy results ≤ 3 years prior to screening indicating the absence of cirrhosis. Alternatively, a non-invasive procedure conducted within 6 months of screening is permitted in countries where allowed
- Monoinfection with HCV genotype (GT) 1a or 1b
- HCV RNA ≥ 104 IU/mL at screening
- Prior treatment and adherence with one course of pegylated interferon alfa and RBV
- The subject's medical records must include sufficient detail of prior treatment with pegylated interferon alfa and RBV (start/stop dates and viral response) to allow for categorization of prior response as either null, partial, breakthrough or relapse.
- Body mass index (BMI) 18-40 kg/m2 inclusive
- Screening ECG without clinically significant abnormalities and with QTcF interval (QT corrected using Fridericia's formula)
- ≤ 450 msec for males and ≤ 470 msec for females.
- Agree to use two forms of highly effective contraception for the duration of the study and for 7 months after the last dose of study medication. Females of childbearing potential must have a negative pregnancy test at screening and baseline.
Exclusion
- Discontinuation of prior treatment with pegylated interferon alfa and RBV due to an adverse event, toxicity reasons or were lost to follow-up
- History of significant cardiac disease
- Exceed criteria delineated in Section 4.2 for laboratory measure thresholds related to leukopenia, neutropenia, anemia, thrombocytopenia, and 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.
- Current abuse of amphetamines, cocaine, opiates, or alcohol. Methadone use is not allowed, however stable buprenorphine maintenance treatment for ≥ 6 months is permitted.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT01435226
Start Date
September 1 2011
End Date
July 1 2013
Last Update
December 17 2013
Active Locations (51)
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1
University of Arizona
Tucson, Arizona, United States, 85724
2
Advanced Clinical Research Institute, LLC
Anaheim, California, United States, 92801
3
California Liver Institute
Beverly Hills, California, United States, 90211
4
SCTI Research Foundation Liver Center
Coronado, California, United States, 92118