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

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis B

Treatments: Drug: Vesatolimod; Drug: Placebo; Drug: TDF

Study type: Interventional

Funder types: Industry

Identifiers

NCT02579382

GS-US-283-1062

2015-002017-30 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 192 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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192 participants in 4 patient groups, including a placebo group

TDF + placebo

Placebo Comparator group

Description:

Main Study Phase: Tenofovir disoproxil fumarate (TDF) 300 mg tablets orally once daily for up to 48 weeks + placebo administered orally once a week (every 7 days) for 12 doses. Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144.

Treatment:

Drug: TDF

Drug: Placebo

TDF + Vesatolimod 1 mg

Experimental group

Description:

Main Study Phase:TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses. Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144.

Treatment:

Drug: TDF

Drug: Vesatolimod

TDF + Vesatolimod 2 mg

Experimental group

Description:

Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses. Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144.

Treatment:

Drug: TDF

Drug: Vesatolimod

TDF + Vesatolimod 4 mg

Experimental group

Description:

Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses. Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144.

Treatment:

Drug: TDF

Drug: Vesatolimod