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GS-5885, GS-9451, Tegobuvir and Ribovirin in Treatment-Experienced Subjects With Chronic Genotype 1a Or 1b Hepatitis C Virus (HCV) Infection

NCT01435226 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2013-12-17

No results posted yet for this study

Summary

This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) Compared with GS-5885, GS-9451 with Tegobuvir or RBV in Treatment-Experienced Subjects with Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

GS-5885

Drug: GS-5885 tablet GS-5885 tablet, 90 mg, QD

DRUG

GS-9451

Drug: GS-9451 tablet GS-9451 tablet, 200 mg QD

DRUG

tegobuvir

tegobuvir 30 mg BID

DRUG

placebo to match tegobuvir

tegobuvir placebo BID

DRUG

placebo to match RBV

Ribovirin placebo BID

DRUG

Ribavirin

Ribavirin (Copegus®) BID (1000 mg for subjects weighing \< 75 kg and 1200 mg for subjects weighing ≥ 75 kg) divided BID

Sponsors & Collaborators

Principal Investigators

  • John McNally, PhD · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-01-31
Completion
2013-07-31

Countries

  • United States
  • Germany

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 NCT01435226 on ClinicalTrials.gov