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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01225380
• Date of registration: 18/10/2010
• Primary sponsor: Gilead Sciences
• Public title: 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
• Scientific title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating 16 and 24 Weeks of Response Guided Therapy With GS-9190, GS-9256, Ribavirin (Copegus®) and Peginterferon Alfa 2a (Pegasys®) in Treatment Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection (Protocol No. GS-US-196-0123)
• Date of first enrolment: October 2010
• Target sample size: 320
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01225380
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Austria, Belgium, Canada, Czech Republic, France, Germany, Italy, Poland, Spain, United Kingdom, United States

Contacts

• Name: Phil Pang
• Affiliation: Gilead Sciences

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Hepatitis C Infection

Intervention(s)

Biological: Pegasys®

Drug: Copegus®

Drug: GS-9190

Drug: GS-9190 placebo

Drug: GS-9256

Drug: GS-9256 placebo

Primary Outcome(s)

Sustained virologic response (SVR) defined as undetectable HCV RNA 24 weeks after treatment cessation [Time Frame: 24 weeks of off-treatment follow-up]

Secondary Outcome(s)

Emergence of viral resistance following initiation of therapy with GS-9190 and GS-9256 [Time Frame: Through up to 48 weeks treatment period, 24 weeks of off-treatment follow-up, and up to 48 weeks of follow-up in the Resistance Registry Substudy]

Long-term assessment of plasma HCV RNA in subjects who achieve SVR [Time Frame: 36 months following Week 72]

Safety and tolerability of therapy as measured by frequency of laboratory abnormalities, reported adverse events, and discontinuations due to adverse events [Time Frame: Through up to 48 weeks treatment period and 24 weeks of off-treatment follow-up]

Viral dynamics and steady state pharmacokinetics of GS-9190 and GS-9256 when administered in combination with PEG and RBV; measured by HCV RNA levels and plasma concentrations of GS-9190 and GS-9256 over time [Time Frame: Through Week 4 of therapy]

Secondary ID(s)

GS-US-196-0123

Source(s) of Monetary Support

Please refer to primary and secondary sponsors