MedTrace Logo

Open-Label Study of Sofusbuvir+Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies

NCT01625338 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 534

Last updated 2015-11-09

Study results available
· View outcomes & findings →

Summary

This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) in combination with ribavirin (RBV) with or without pegylated interferon (Peg-IFN) in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead HCV study and have not achieved sustained virologic response (SVR).

Conditions

  • Chronic Hepatitis C

Interventions

DRUG

SOF

SOF 400 mg tablet administered orally once daily

DRUG

RBV

RBV 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

Peg-IFN

Peg-IFN 180 μg administered once weekly by subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • Bittoo Kanwar, MD · Gilead Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-10-31
Completion
2014-12-31

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • Czechia
  • Estonia
  • France
  • Germany
  • Italy
  • Netherlands
  • New Zealand
  • Poland
  • Puerto Rico
  • 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 NCT01625338 on ClinicalTrials.gov