Status:
TERMINATED
Efficacy and Safety Study of GS-9450 Treatment for 6 Months in Patients With Chronic Hepatitis C Virus Infection
Lead Sponsor:
Gilead Sciences
Conditions:
HCV Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 chro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
307 Patients enrolled
Trial Details
Trial ID
NCT00874796
Start Date
May 1 2009
End Date
July 1 2010
Last Update
February 4 2014
Active Locations (73)
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1
Phoenix, Arizona, United States
2
Tucson, Arizona, United States
3
Anaheim, California, United States
4
Beverly Hills, California, United States