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GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) in Interferon Ineligible or Intolerant Subjects With Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection

NCT01434498 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 163

Last updated 2013-12-20

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; GS-5885, GS-9451 and Tegobuvir; GS-5885, GS-9451 and Ribavirin in Interferon Ineligible or Intolerant Subjects with Chronic Genotype 1a or 1b HCV Infection.

Conditions

  • Chronic Genotype 1a or 1b HCV Infection

Interventions

DRUG

GS-5885 tablet

GS-5885 tablet, 90 mg, QD

DRUG

GS-9451 tablet

GS-9451 tablet, 200 mg QD

DRUG

tegobuvir capsule

tegobuvir capsule, 30 mg BID

DRUG

ribavirin tablet

ribavirin tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)

DRUG

placebo matching ribavirin tablet

placebo matching ribavirin tablet, BID

DEVICE

placebo matching tegobuvir capsule

placebo matching tegobuvir capsule, 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
2013-01-31

Countries

  • United States
  • Canada
  • Puerto Rico

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 NCT01434498 on ClinicalTrials.gov