Status:
COMPLETED
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
Lead Sponsor:
Gilead Sciences
Conditions:
Hepatitis C Virus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- Treatment experienced and naïve subjects
- Chronic genotype 4 HCV-infection
- Not co-infected with HIV
- Screening laboratory values within defined thresholds
- Use of highly effective contraception methods
- Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.
Exclusion
- History of any other clinically significant chronic liver disease
- Pregnant or nursing female or male with pregnant female partner
- History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
- Excessive alcohol ingestion or significant drug abuse
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT01838590
Start Date
March 1 2013
End Date
August 1 2014
Last Update
May 22 2015
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Al Mansurah, Egypt
2
Cairo, Egypt