A Study of 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:	Active, not recruiting
Conditions:	Hepatitis, Hepatitis
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - 65
Updated:	4/4/2019
Start Date:	November 10, 2015
End Date:	May 2019

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Safety and Efficacy of GS-9620 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Subjects With Chronic Hepatitis B and Who Are Currently Not on Treatment

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.

Key Inclusion Criteria:

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

- Chronic HBV infection

- HBV 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), 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.

We found this trial at

sites

Clinical Trial Facility in Catonsville Maryland

Catonsville, Maryland 21228

from

Catonsville, MD