Safety and Efficacy of SOF/VEL/VOX FDC for 8 Weeks and SOF/VEL for 12 Weeks in Adults Chronic Genotype 3 HCV Infection and Cirrhosis
Status: | Completed |
---|---|
Conditions: | Infectious Disease, Infectious Disease, Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/7/2019 |
Start Date: | December 23, 2015 |
End Date: | January 2, 2017 |
A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 8 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks in Subjects With Chronic Genotype 3 HCV Infection and Cirrhosis
The primary objective of this study is to evaluate the efficacy, safety, and tolerability of
treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC)
for 8 weeks and of treatment with sofosbuvir/velpatasvir (SOF/VEL) FDC for 12 weeks in
participants naive to direct-acting antivirals (DAA) with chronic genotype 3 hepatitis C
virus (HCV) infection and cirrhosis.
treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC)
for 8 weeks and of treatment with sofosbuvir/velpatasvir (SOF/VEL) FDC for 12 weeks in
participants naive to direct-acting antivirals (DAA) with chronic genotype 3 hepatitis C
virus (HCV) infection and cirrhosis.
Key Inclusion Criteria:
- Willing and able to provide written informed consent
- HCV RNA ≥ 10^4 IU/mL at screening
- Chronic genotype 3 HCV infection (≥ 6 months)
- Presence of cirrhosis
- HCV treatment naive or treatment experienced with an interferon (IFN)-based regimen
- Use of protocol specified methods of contraception
Key Exclusion Criteria:
- Current or prior history of clinically significant illness that may interfere with
participation in the study
- Screening ECG with clinically significant abnormalities
- Laboratory parameters outside the acceptable range at screening
- Pregnant or nursing female
- Chronic liver disease not caused by HCV
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
35
sites
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