MedTrace Logo

Sofosbuvir and Ribavirin in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection

NCT01682720 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 421

Last updated 2014-10-09

Study results available
· View outcomes & findings →

Summary

This study will evaluate the safety, tolerability, and antiviral efficacy of GS-7977 with ribavirin (RBV) in participants with genotype 2 or 3 hepatitis C virus (HCV) infection.

Conditions

  • Hepatitis C

Interventions

DRUG

SOF

Sofosbuvir (SOF) 400 mg tablet administered orally once daily

DRUG

RBV

Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

DRUG

Placebo to match SOF

Placebo to match SOF administered orally once daily

DRUG

Placebo to match RBV

Placebo to match RBV administered orally in a divided daily dose

Sponsors & Collaborators

Principal Investigators

  • Rob Hyland, DPhil · Gilead Sciences Study Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-10-31
Completion
2014-01-31

Countries

  • Austria
  • Estonia
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Spain
  • Sweden
  • United Kingdom

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 NCT01682720 on ClinicalTrials.gov