Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir in Adults With Chronic HCV Infection Who Have Previously Received Treatment With Direct-Acting Antiviral Therapy
Status: | Completed |
---|---|
Conditions: | Infectious Disease, Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/7/2019 |
Start Date: | November 11, 2015 |
End Date: | June 21, 2017 |
A Phase 3, Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects With Chronic HCV Infection
The primary objectives of this study are to evaluate the safety and efficacy of treatment
with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C
virus (HCV) infection who have previously received treatment with direct-acting antiviral
therapy.
Participants randomized to placebo may be eligible for deferred treatment with active
SOF/VEL/VOX.
with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C
virus (HCV) infection who have previously received treatment with direct-acting antiviral
therapy.
Participants randomized to placebo may be eligible for deferred treatment with active
SOF/VEL/VOX.
Key Inclusion Criteria:
- Willing and able to provide written informed consent
- HCV RNA ≥ 10^4 IU/mL at screening
- Chronic HCV infection (≥ 6 months)
- Treatment experienced with a direct acting antiviral medication for HCV
- 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 results outside of acceptable ranges 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
44
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