Sofosbuvir (GS-7977) in Combination With PEG and Ribavirin for 12 Weeks in Treatment Experienced Subjects With Chronic HCV Infection Genotype 2 or 3
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/27/2013 |
| Start Date: | February 2013 |
| End Date: | July 2014 |
| Contact: | Meredith Gonzalez |
| Email: | meredith.gonzalez@gilead.com |
A Phase 2, Open-Label Study of Sofosbuvir (GS-7977) in Combination With PEG and Ribavirin in Treatment Experienced Subjects With Chronic HCV Infection Genotype 2 or 3
The purpose of this study is to evaluate the safety, tolerability and antiviral efficacy of
sofosbuvir (GS-7977) in combination with PEG and Ribavirin administered for 12 weeks in
subjects with chronic HCV genotype 2 or 3 that have previously received an interferon-based
regimen
Inclusion Criteria:
- Infection with HCV GT 2 or 3
- Cirrhosis determination
- Subject is treatment-experienced
- Screening laboratory values within defined thresholds
- Subject has not been treated with any investigational drug or device within 30 days
of the Screening visit
- Use of highly effective contraception methods if female of childbearing potential or
sexually active male
Exclusion Criteria:
- Prior exposure to an direct-acting antiviral targeting the HCV NS5B polymerase
- Pregnant or nursing female or male with pregnant female partner
- Current or prior history of clinical hepatic decompensation
- 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
