Clinical Trials Directory

Trials / Completed

CompletedNCT01838590

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

A Phase 3, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naïve and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 HCV Infection.

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
103 (actual)
Sponsor
Gilead Sciences · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGSOFSofosbuvir (SOF) 400 mg tablet administered orally once daily
DRUGRBVRibavirin (RBV) 200 mg tablets administered orally in a divided daily dose (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Timeline

Start date
2013-03-01
Primary completion
2014-05-01
Completion
2014-08-01
First posted
2013-04-24
Last updated
2015-05-22
Results posted
2015-05-22

Locations

2 sites across 1 country: Egypt

Source: ClinicalTrials.gov record NCT01838590. Inclusion in this directory is not an endorsement.