MedTrace Logo

Phase 3 Study of Sofosbuvir and Ribavirin

NCT01497366 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 527

Last updated 2014-04-02

Study results available
· View outcomes & findings →

Summary

This study was to assess the safety and efficacy of sofosbuvir (GS-7977; PSI-7977) in combination with ribavirin (RBV) administered for 12 weeks compared with pegylated interferon (PEG)/RBV administered for 24 weeks in treatment-naive patients with Hepatitis C (HCV) genotype 2 or 3. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12). This was a non-inferiority study, and if non-inferiority was demonstrated, the study was then allowed to test for superiority.

Conditions

  • Hepatitis C

Interventions

DRUG

Sofosbuvir

Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily

DRUG

PEG

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

DRUG

RBV

Ribavirin (RBV) administered as 200 mg tablets up to 1200 mg in a divided daily dose * Dose of sofosbuvir+RBV group based on baseline weight: \< 75kg = 1000 mg and ≥ 75 kg = 1200 mg * Dose of PEG+RBV group: 800 mg

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-01-31
Completion
2013-04-30

Countries

  • United States
  • Australia
  • Canada
  • Italy
  • Netherlands
  • New Zealand
  • Puerto Rico
  • Sweden

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 NCT01497366 on ClinicalTrials.gov