GS-7977 + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection (FUSION)
Status: | |
---|---|
Conditions: | Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | Any |
Updated: | 7/16/2012 |
Start Date: | June 2012 |
End Date: | July 2013 |
Contact: | Meredith Gonzalez |
Email: | 7977Phase3@gilead.com |
A Phase 3, Multicenter, Randomized, Double-Blind, Study to Investigate the Efficacy and Safety of GS-7977 + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection
GS7977 in combination with ribavirin(RBV) administered for 12 or 16 weeks is safe and
effective in patients with Hepatitis C (HCV) genotype 2 or 3 (GT-2 or GT-3) as assessed by
the rate of sustained viral response (SVR) 12 weeks after discontinuation of therapy (SVR12)
Inclusion Criteria:
- Infection with HCV GT 2 or 3
- Cirrhosis determination
- Subject meets the following classifications:
• Prior treatment failure
- 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
36
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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