Trial Search Results
GS-5885 Alone or in Combination With GS-9451 With Peginterferon Alfa 2a and Ribavirin in Treatment Chronic Genotype 1 Hepatitis C Virus
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.
Stanford is currently not accepting patients for this trial.
- Drug: GS-5885
- Drug: GS-9451
- Biological: peginterferon alfa-2a
- Drug: ribavirin tablet
- Drug: GS-9451 Placebo
- Males and females 18-70 years of age
- 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.
- Pregnant female or male with pregnant female partner
- 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
Ages Eligible for Study
18 Years - 70 Years
Genders Eligible for Study