Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection

• Status: Completed
• Trial end date: 2016-05-09
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the antiviral efficacy, safety, and tolerability of combination therapy with oral regimens for the treatment of chronic hepatitis C virus (HCV) infection.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Sofosbuvir

Criteria

Key Inclusion Criteria:

• Willing and able to provide written informed consent

• Chronic HCV infection

• Cirrhosis determination (liver biopsy may be required)

• Screening laboratory values within specified limits

• Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

• Specific genotype, prior medical history, or concurrent disease as required by the specific study group

Key Exclusion Criteria:

• History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol

• Pregnant or nursing female, or male with pregnant female partner

• Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage)

• Use of any prohibited concomitant medications

Note: Other protocol defined Inclusion/Exclusion criteria may apply.