HCV Infection Clinical Trial
Official title:
A Phase 2b, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of GS 9450 in Adults With Chronic Hepatitis C Virus Infection (GS-US-227-0106)
This is a Phase 2b, randomized, double-blind, parallel-group, placebo-controlled,
multicenter study investigating the safety, tolerability and efficacy of two oral doses of
GS-9450 in adults with chronic Hepatitis C Virus (HCV). Approximately 240 subjects 18-65
years of age who meet study entry criteria will be randomized (in other words, selected at
random, like flipping a coin) to one of three treatment groups (80 subjects per treatment
group) as follows:GS-9450 10 mg once daily,GS-9450 40 mg once daily, or matching placebo
once daily.
Following randomization, subjects will return within seven business days for a Baseline (Day
1) visit, at which time study medication will be dispensed and subjects will enter a 26 week
treatment phase. During the treatment phase, subjects will receive study drug once daily for
24 weeks and then taper off of study drug over the following 2 weeks by receiving study drug
once every other day for one week and then every 3 days for one week. Following completion
of the treatment phase, subjects will enter a 4-week off-treatment follow-up phase.
Status | Terminated |
Enrollment | 307 |
Est. completion date | July 2010 |
Est. primary completion date | April 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Adult subjects, ages 18-65 - Chronic HCV infection, defined as having documented HCV infection (antibody or RNA positivity) at least 6 months prior to Baseline (Day 1) with HCV viremia at screening - Screening Knodell necroinflammatory score >= 3 based on liver biopsy evaluation (as determined by local pathologist) conducted anytime during the 45-day screening period - ALT > the upper limit of the normal range (ULN) but < 10 X ULN at the screening visit - Previously failed pegylated interferon-based HCV therapy in combination with ribavirin therapy, or is unable to tolerate or has contraindications to receiving interferon or ribavirin therapy - BMI between 19 and 36 kg/m2 (inclusive) - Creatinine clearance >= 70 mL/min - absolute neutrophil count >= 1000/mm3 - Hemoglobin > 10 g/dL - Have no clinical or laboratory evidence of hepatic decompensation Exclusion Criteria: - Decompensated liver disease - Child-Pugh grade B or C cirrhosis - Evidence of hepatocellular carcinoma - Positive urine drug screen for cocaine or amphetamines - Infection with HCV genotype 3 - Co-infection with hepatitis B virus or human immunodeficiency virus - Pancreatitis - Recent significant infection or symptoms of infection - Autoimmune disorders - Any history of seizure - Is a public transportation operator (pilot of airplane or ship; air traffic controller; bus, train or subway driver) or operates heavy construction machinery - Transplantation - History of malignancy - Current excessive alcohol ingestion, averaging > 3 drinks/day for females and > 4 drinks/day for males - History of or current binge drinking |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Gilead Sciences |
United States, Canada, Germany, Poland, Puerto Rico, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Histologic response, defined as a >= 2-point decrease in Knodell necroinflammatory score with no concurrent worsening in the Knodell fibrosis score, at Week 24 . | Week 24 on-treatment | No | |
Secondary | Change (absolute, percent) from baseline in the Knodell necroinflammatory score | Baseline to Week 24 | No | |
Secondary | Change (absolute, percent) from pretreatment in alanine aminotransferase (ALT) levels | Baseline to Week 24 | No | |
Secondary | Percentage of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities | Up to 24 weeks plus 30 days following the last dose of study drug | Yes | |
Secondary | Change (absolute, percent) from baseline in cytokeratin-18 caspase cleavage fragment levels | Baseline to Week 24 | No | |
Secondary | Change from baseline in hepatic collagen staining area as measured by morphometry of liver biopsy specimens | Baseline to Week 24 | No | |
Secondary | Change from baseline in the percent of apoptotic cells | Change from baseline in the percent of apoptotic cells (transferase deoxyuridine triphosphate [dUTP] nick end labeling [TUNEL] positive) as measured by TUNEL staining of liver biopsy specimens | Baseline to Week 24 | No |
Secondary | Change from baseline in percent of anti-M30 monoclonal antibody-positive hepatocytes | Change from baseline in percent of anti-M30 monoclonal antibody-positive hepatocytes (for cytokeratin-18 neoantigen expression) as measured by immunohistochemical staining of liver biopsy specimens | Baseline to Week 24 | No |
Secondary | Change From Baseline in HCV RNA | Baseline to to Week 24 | No |
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