Safety and Efficacy of Sofosbuvir + Velpatasvir With or Without Ribavirin in Treatment-Naive Adults With Chronic HCV Infection
Status: | Completed |
---|---|
Conditions: | Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/16/2018 |
Start Date: | April 2013 |
End Date: | August 2014 |
A Phase 2, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir + GS-5816 for 12 Weeks in Treatment-Naive Subjects With Chronic HCV Infection
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and
tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV)
in treatment-naive adults with chronic genotype (GT) 1, 2, 3, 4, 5, or 6 hepatitis C virus
(HCV) infection.
tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV)
in treatment-naive adults with chronic genotype (GT) 1, 2, 3, 4, 5, or 6 hepatitis C virus
(HCV) infection.
Inclusion Criteria:
- Chronic HCV infection
- Body mass index (BMI) ≥ 18 kg/m^2
- HCV RNA ≥ 10000 IU/mL at screening
- Use of highly effective contraception methods if female of childbearing potential or
sexually active male
- Must not have cirrhosis
Exclusion Criteria:
- Current or prior history of clinically significant illness other than HCV
- Screening ECG with clinically significant abnormalities
- Prior exposure to HCV specific direct acting antiviral agent
- Prior treatment of HCV with interferon or ribavirin
- Pregnant or nursing female or male with pregnant female partner
- Chronic liver disease of non-HCV etiology
- Hepatitis B
- Active drug abuse
- Use of any prohibited concomitant medications
We found this trial at
51
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Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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University of Miami A private research university with more than 15,000 students from around the...
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Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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340 W 10th St #6200
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
(317) 274-3772
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Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
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Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
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Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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