Status:
COMPLETED
A Study of Response-Guided Duration of Combination Therapy With GS-9190, GS-9256, Pegasys® and Copegus® in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C
Lead Sponsor:
Gilead Sciences
Conditions:
Chronic Hepatitis C Infection
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of response-guided duration of therapy with GS-9190 and GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ri...
Eligibility Criteria
Inclusion
- Adult subjects 18 to 70 years of age
- Chronic HCV infection for at least 6 months prior to Baseline (Day 1)
- Liver biopsy results (performed no more than 2 years prior to Screening) indicating the absence of cirrhosis
- Monoinfection with HCV genotype 1a or 1b
- HCV treatment-naïve
- Body mass index (BMI) between 18 and 36 kg/m2
- Creatinine clearance \>/= 50 mL/min
- Subject agrees to use highly effective contraception methods if female of childbearing potential or sexually active male.
- Screening laboratory values within defined thresholds for ALT, AST, leukopenia, neutropenia, anemia, thrombocytopenia, thyroid stimulating hormone (TSH), potassium, magnesium
Exclusion
- Autoimmune disease
- Decompensated liver disease or cirrhosis
- Poorly controlled diabetes mellitus
- Severe psychiatric illness
- Severe chronic obstructive pulmonary disease (COPD)
- Serological evidence of co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotype
- Suspicion of hepatocellular carcinoma or other malignancy (with exception of certain skin cancers)
- History of hemoglobinopathy
- Known retinal disease
- Subjects who are immunosuppressed
- Subjects with known, current use of amphetamines, cocaine, opiates (i.e., morphine, heroin), methadone, or ongoing alcohol abuse
- Subjects who are on or are expected to be on a potent cytochrome P450 (CYP) 3A4 or Pgp inhibitor, or a QT prolonging medication within 2 weeks of Baseline (Day 1) or during the study
- Subjects must have no history of clinically significant cardiac disease, including a family history of Long QT syndrome, and no relevant electrocardiogram (ECG) abnormalities at screening
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
324 Patients enrolled
Trial Details
Trial ID
NCT01225380
Start Date
October 1 2010
End Date
September 1 2013
Last Update
January 28 2014
Active Locations (114)
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1
Mayo Clinic
Phoenix, Arizona, United States, 85054
2
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
3
Scripps Clinic
La Jolla, California, United States, 92037
4
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048