Efficacy and Safety Study of GS-9450 Treatment for 6 Months in Patients With Chronic Hepatitis C Virus Infection

Gilead Sciences logo

Gilead Sciences

Status and phase

Terminated
Phase 2

Conditions

HCV Infection

Treatments

Drug: GS-9450
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00874796
GS-US-227-0106

Details and patient eligibility

About

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.

Enrollment

307 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

307 participants in 3 patient groups, including a placebo group

GS-9450 10 mg/day
Experimental group
Description:
GS-9450 taken as one 10 mg capsule by mouth once daily
Treatment:
Drug: GS-9450
GS-9450 40 mg/day
Experimental group
Description:
GS-9450 taken as one 40 mg capsule by mouth once daily
Treatment:
Drug: GS-9450
Placebo
Placebo Comparator group
Description:
Placebo taken as one placebo capsule by mouth once daily
Treatment:
Drug: Placebo

Trial contacts and locations

73

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems