Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Non-Genotype 1 HCV Infection
Status: | Completed |
---|---|
Conditions: | Infectious Disease, Infectious Disease, Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/27/2019 |
Start Date: | February 16, 2015 |
End Date: | January 26, 2016 |
A Phase 2, Global, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-9857 Plus Sofosbuvir/GS-5816 Fixed Dose Combination in Subjects With Chronic Non-Genotype 1 HCV Infection
The primary objectives of the study are to evaluate the safety, tolerability, and efficacy of
voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) in
adults with chronic non genotype 1 hepatitis C virus (HCV) infection.
voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) in
adults with chronic non genotype 1 hepatitis C virus (HCV) infection.
Key Inclusion Criteria:
- Individuals with chronic HCV infection
- HCV RNA ≥10^4 IU/mL at screening
- HCV genotypes 2, 3, 4, 5, or 6
- Cirrhosis determination; a liver biopsy may be required
- Screening laboratory values within defined thresholds
- Use of two contraception methods if female of childbearing potential or sexually
active male
Key Exclusion Criteria:
- Pregnant or nursing female
- Current or prior history of hepatic decompensation
- Hepatocellular carcinoma (HCC) or other clinically significant malignancy
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- History of clinically significant illness or any other medical disorder that may
interfere with the individual's treatment, assessment or compliance with the protocol
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
32
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University of Chicago One of the world's premier academic and research institutions, the University of...
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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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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
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Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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340 W 10th St #6200
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
(317) 274-3772

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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