Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naïve and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | October 2012 |
| End Date: | December 2013 |
| Contact: | Anupma Roy |
| Email: | anupma.roy@gilead.com |
This is a research study to evaluate the safety, tolerability, and anti-viral activity of
sofosbuvir with ribavirin in Egyptian adults with genotype 4 hepatitis C infection.
Inclusion Criteria:
- First generation Egyptian. Subjects must have been born in Egypt and can trace both
maternal and paternal Egyptian ancestry.
- 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 Criteria:
- 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
We found this trial at
1
site
Click here to add this to my saved trials
