Overview

This trial is active, not recruiting.

Condition chronic hepatitis b
Treatments tdf, vesatolimod, placebo
Phase phase 2
Sponsor Gilead Sciences
Start date November 2015
End date January 2017
Trial size 192 participants
Trial identifier NCT02579382, 2015-002017-30, GS-US-283-1062

Summary

The study will 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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose treatment
Masking participant, investigator
Arm
(Placebo Comparator)
TDF + placebo
tdf Viread®
300 mg tablets administered orally once daily
placebo
Placebo administered orally once a week (every 7 days) for 12 doses
(Experimental)
TDF + vesatolimod 1 mg
tdf Viread®
300 mg tablets administered orally once daily
vesatolimod
Tablets administered orally once a week (every 7 days) for 12 doses
(Experimental)
TDF + vesatolimod 2 mg
tdf Viread®
300 mg tablets administered orally once daily
vesatolimod
Tablets administered orally once a week (every 7 days) for 12 doses
(Experimental)
TDF + vesatolimod 4 mg
tdf Viread®
300 mg tablets administered orally once daily
vesatolimod
Tablets administered orally once a week (every 7 days) for 12 doses

Primary Outcomes

Measure
Mean Change (Measured in log10 IU/mL) in Serum Hepatitis B Surface Antigen (HBsAg) from Baseline at Week 24
time frame: Baseline; Week 24

Secondary Outcomes

Measure
Proportions of Participants with Hepatitis B e Antigen (HBeAg) Loss and Seroconversion at Week 24
time frame: Baseline; Week 24
Proportions of Participants with Hepatitis B e Antigen (HBeAg) Loss and Seroconversion at Week 48
time frame: Baseline; Week 48
Proportions of Participants with HBsAg Loss and Seroconversion at Week 24
time frame: Baseline; Week 24
Proportions of Participants with HBsAg Loss and Seroconversion at Week 48
time frame: Baseline; Week 48
Mean Change (Measured in log10 IU/mL) in HBsAg from Baseline at Week 12
time frame: Baseline; Week 12
Mean Change (Measured in log10 IU/mL) in HBsAg from Baseline at Week 48
time frame: Baseline; Week 48
Proportions of Participants with a ≥ 0.5 log10 IU/mL Decline in Serum HBsAg Titers from Baseline at Week 12
time frame: Baseline; Week 12
Proportions of Participants with a ≥ 0.5 log10 IU/mL Decline in Serum HBsAg Titers from Baseline at Week 24
time frame: Baseline; Week 24
Proportions of Participants with a ≥ 0.5 log10 IU/mL Decline in Serum HBsAg Titers from Baseline at Week 48
time frame: Baseline; Week 48
Proportions of Participants with Hepatitis B Virus (HBV) DNA < Lower Limit of Quantitation (LLOQ) at Week 24
time frame: Week 24
Proportions of Participants with Hepatitis B Virus (HBV) DNA < Lower Limit of Quantitation (LLOQ) at Week 48
time frame: Week 48
Proportion of Participants Experiencing Virologic Breakthrough
time frame: Up to Week 12
Proportion of Participants with Drug Resistance Mutations
time frame: Up to Week 48
Pharmacokinetic (PK) Parameter: AUClast of Vesatolimod
time frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
PK Parameter: AUCinf of Vesatolimod
time frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
PK Parameter: %AUCexp of Vesatolimod
time frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
PK Parameter: Cmax of Vesatolimod
time frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
PK Parameter: Clast of Vesatolimod
time frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
PK Parameter: Tmax of Vesatolimod
time frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
PK Parameter: Tlast of Vesatolimod
time frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
PK Parameter: T1/2 of Vesatolimod
time frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
PK Parameter: CL/F of Vesatolimod
time frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose

Eligibility Criteria

All participants from 18 years up to 65 years old.

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.

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by Gilead Sciences.