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Efficacy and Safety of Sofosbuvir Plus Ribavirin in Japanese Adults With Chronic Genotype 2 HCV Infection

NCT01910636 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2015-03-24

Study results available
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Summary

This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) plus ribavirin (RBV) in Japanese participants with chronic genotype 2 hepatitis C virus (HCV) infection.

Conditions

  • Hepatitis C

Interventions

DRUG

Sofosbuvir

Sofosbuvir 400 mg tablet administered orally once daily

DRUG

RBV

Ribavirin (RBV) tablets were administered orally in a divided daily dose according to package insert weight-based dosing according to the approved Copegus labeling in Japan (\< 60 kg = 600 mg , \> 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg)

Sponsors & Collaborators

Principal Investigators

  • Steven Knox · Gilead Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2014-03-31
Completion
2014-06-30

Countries

  • Japan

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 NCT01910636 on ClinicalTrials.gov