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Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection

NCT01838590 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2015-05-22

Study results available
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Summary

This study is to to evaluate the safety, tolerability, and efficacy of sofosbuvir (SOF) plus ribavirin (RBV) in Egyptian adults with genotype 4 hepatitis C virus (HCV) infection.

Conditions

  • Hepatitis C Virus

Interventions

DRUG

SOF

Sofosbuvir (SOF) 400 mg tablet administered orally once daily

DRUG

RBV

Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Sponsors & Collaborators

Principal Investigators

  • Kathryn Kersey · 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
2013-03-31
Primary Completion
2014-05-31
Completion
2014-08-31

Countries

  • Egypt

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 NCT01838590 on ClinicalTrials.gov