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GS-5885, GS-9451 With Peginterferon Alfa 2a (PEG) and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 Hep C Virus Infection and IL28B CC Genotype

NCT01384383 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2014-02-03

No results posted yet for this study

Summary

This is a Phase 2, randomized, open-label exploratory study that will examine the antiviral efficacy, safety, and tolerability of Response guided treatment (RGT) with GS-5885 + GS-9451 + PEG/RBV (6 or 12 weeks), or Peginterferon Alfa 2a (PEG)/Ribavirin (RBV)alone (24 weeks) in treatment naïve subjects with chronic Hep C (HCV) infection with genotype (GT) 1 and IL28B CC genotype.

Conditions

  • Chronic Hepatitis C

Interventions

DRUG

GS-5885

GS-5885 30 mg tablet administered orally once daily

DRUG

GS-9451

GS-9451 200 mg tablet administered orally once daily

DRUG

RBV

Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

DRUG

PEG

Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United States
  • Australia
  • Canada
  • New Zealand

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01384383 on ClinicalTrials.gov