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Sofosbuvir in Combination With Pegylated Interferon and Ribavirin and in Treatment-Naive Hepatitis C-infected Patients

NCT01188772 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2014-04-21

Study results available
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Summary

Genotype 1: Participants with genotype 1 hepatitis C (HCV) infection were randomized to receive sofosbuvir (GS-7977; PSI-7977) 200 mg or 400 mg, or matching placebo, plus pegylated interferon alfa 2a (PEG) and ribavirin (RBV) for 12 weeks, followed by PEG+RBV for an up to an additional 36 weeks. Randomization was stratified by IL28B status (CC, CT, TT) and HCV RNA level (\< 800,000 IU/ml or ≥ 800,000 IU/ml) at baseline. Participants were randomized in a 2:2:1 manner; those who achieved an extended rapid virologic response (eRVR) (HCV RNA \< lower limit of detection \[15 IU/mL\] from Weeks 4 through 12) received an additional 12 weeks of PEG+RBV. Subjects not achieving eRVR received an additional 36 weeks of PEG+RBV.

Genotype 2 and 3: Participants with genotype 2 or 3 hepatitis C (HCV) received sofosbuvir 400 mg plus PEG+RBV for 12 weeks.

Conditions

  • Hepatitis C Virus

Interventions

DRUG

Sofosbuvir

Sofosbuvir tablets were administered orally once daily.

DRUG

Placebo to match sofosbuvir

Placebo tablets to match sofosbuvir were administered orally once daily.

DRUG

PEG

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

DRUG

RBV

Ribavirin (RBV) was administered as a tablet orally according to package insert dosing recommendations (Genotype 1: \< 75kg = 1000 mg and ≥ 75 kg = 1200 mg; Genotype 2/3: 800 mg).

Sponsors & Collaborators

Principal Investigators

  • Robert H. Hyland, DPhil · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-04-30
Completion
2012-05-31

Countries

  • United States
  • Puerto Rico

Study Locations

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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 NCT01188772 on ClinicalTrials.gov