Status:
COMPLETED
Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Voxilaprevir in Adults With Chronic Hepatitis C Virus Infection
Lead Sponsor:
Gilead Sciences
Conditions:
Hepatitis C Virus Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The primary objective of the study is to evaluate the safety and tolerability of voxilaprevir (formerly GS-9857) alone or with sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) and antiv...
Eligibility Criteria
Inclusion
- Key
- Chronic genotype 1-4 HCV infection
- For Cohorts 1-9, HCV RNA ≥ 100,000 IU/mL at screening (no HCV RNA restriction for Cohort 10)
- Screening laboratory values within defined thresholds
- Use of two effective contraception methods if female of childbearing potential or sexually active male
- Key
Exclusion
- Pregnant or nursing female or male with pregnant female partner
- Presence of cirrhosis
- Prior exposure to approved or experimental HCV Protease Inhibitors
- Co-infection with HIV or hepatitis B virus (HBV)
- Current or prior history of clinical hepatic decompensation
- Chronic use of systemic immunosuppressive agents
- History of clinically significant illness or any other medical disorder that may interfere with participant's treatment, assessment or compliance with the protocol
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
June 13 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2015
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT02185794
Start Date
June 13 2014
End Date
September 28 2015
Last Update
September 17 2020
Active Locations (11)
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1
Costa Mesa, California, United States
2
DeLand, Florida, United States
3
Orlando, Florida, United States
4
Kansas City, Missouri, United States