Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Voxilaprevir in Adults With Chronic Hepatitis C Virus Infection
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 92
Exclusion Criteria
- Presence of cirrhosis
- History of clinically significant illness or any other medical disorder that may interfere with participant's treatment, assessment or compliance with the protocol
- Chronic use of systemic immunosuppressive agents
- ...
- Presence of cirrhosis
- History of clinically significant illness or any other medical disorder that may interfere with participant's treatment, assessment or compliance with the protocol
- Chronic use of systemic immunosuppressive agents
- Prior exposure to approved or experimental HCV Protease Inhibitors
- Current or prior history of clinical hepatic decompensation
- Pregnant or nursing female or male with pregnant female partner
- Co-infection with HIV or hepatitis B virus (HBV)
Summary
- Conditions
- Hepatitis C Virus Infection
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Exclusion Criteria
- Presence of cirrhosis
- History of clinically significant illness or any other medical disorder that may interfere with participant's treatment, assessment or compliance with the protocol
- Chronic use of systemic immunosuppressive agents
- ...
- Presence of cirrhosis
- History of clinically significant illness or any other medical disorder that may interfere with participant's treatment, assessment or compliance with the protocol
- Chronic use of systemic immunosuppressive agents
- Prior exposure to approved or experimental HCV Protease Inhibitors
- Current or prior history of clinical hepatic decompensation
- Pregnant or nursing female or male with pregnant female partner
- Co-infection with HIV or hepatitis B virus (HBV)
Tracking Information
- NCT #
- NCT02185794
- Collaborators
- Not Provided
- Investigators
- Study Director: Gilead Study Director Gilead Sciences
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