Study to Evaluate the Safety, Tolerability, and Efficacy of Vesatolimod in Combination With Tenofovir Disoproxil Fumarate (TDF) in Adults With Chronic Hepatitis B (CHB) Infection Who Are Currently Not Being Treated

• Status: Completed
• Trial end date: 2019-05-03
• Target enrollment: 0
• Participant gender: All

Summary

The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of vesatolimod (formerly GS-9620) in adults with chronic hepatitis B (CHB) infection who are currently not being treated.

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

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Tenofovir; Vesatolimod

Criteria

Key Inclusion Criteria:

• Adult males or females between the ages of 18-65

• Chronic hepatitis B virus (HBV) infection

• HBV deoxyribonucleic acid (DNA ) ≥ 2000 IU/mL at screening

Key Exclusion Criteria:

• Extensive bridging fibrosis or cirrhosis

• Received oral antiviral treatment for HBV or prolonged therapy with immune-modulators or biologics within 3 months of screening

• Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV) or hepatitis D virus (HDV)

• Chronic liver disease other than HBV

• Lactating or pregnant females or those that wish to become pregnant during the course of the study

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