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.

Lead Sponsor:

Gilead Sciences

Stanford Investigator(s):

Intervention(s):

  • Drug: GS-5885
  • Drug: GS-9451
  • Biological: peginterferon alfa-2a
  • Drug: ribavirin tablet
  • Drug: GS-9451 Placebo

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - 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.

Exclusion Criteria:

   - 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
   the study.

Ages Eligible for Study

18 Years - 70 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mindie H. Nguyen, MD
650-498-7878
Not Recruiting