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Sofosbuvir With Pegylated Interferon and Ribavirin Hepatitis C Virus (HCV) Genotypes 1,4,5,6

NCT01329978 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 332

Last updated 2014-05-26

Study results available
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Summary

The purpose of this study is to assess the safety, tolerability, and efficacy of sofosbuvir (GS-7977; PSI-7977) administered in combination with pegylated interferon and ribavirin (PEG/RBV) in treatment-naive patients with HCV genotypes 1,4,5,6, or indeterminate genotype.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

Sofosbuvir

Sofosbuvir (SOF) administered as a 400 mg tablet 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

Principal Investigators

  • Robert H. Hyland, DPhil · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States
  • 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 NCT01329978 on ClinicalTrials.gov