Overview

This trial is active, not recruiting.

Condition chronic hepatitis b
Treatments tdf, gs-9620, gs-9620 placebo
Phase phase 2
Sponsor Gilead Sciences
Start date November 2015
End date December 2016
Trial size 175 participants
Trial identifier NCT02579382, 2015-002017-30, GS-US-283-1062

Summary

The study will evaluate the safety, tolerability, and efficacy of 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
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Placebo Comparator)
TDF + placebo to match GS-9620
tdf Viread®
TDF 300 mg tablets administered orally once daily
gs-9620 placebo
Placebo to match GS-9620 administered orally once a week (every 7 days) for 12 doses
(Experimental)
TDF + GS-9620 1 mg
tdf Viread®
TDF 300 mg tablets administered orally once daily
gs-9620
GS-9620 tablets administered orally once a week (every 7 days) for 12 doses
(Experimental)
TDF + GS-9620 2 mg
tdf Viread®
TDF 300 mg tablets administered orally once daily
gs-9620
GS-9620 tablets administered orally once a week (every 7 days) for 12 doses
(Experimental)
TDF + GS-9620 4 mg
tdf Viread®
TDF 300 mg tablets administered orally once daily
gs-9620
GS-9620 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
time frame: Baseline, Week 24

Secondary Outcomes

Measure
Proportions of participants with hepatitis B e antigen (HBeAg) loss and seroconversion
time frame: Baseline, Weeks 24 and 48
Proportions of participants with HBsAg loss and seroconversion
time frame: Baseline, Weeks 24 and 48
Mean change (measured in log10 IU/mL) in HBsAg from baseline
time frame: Baseline, Weeks 12 and 48
Proportions of participants with a ≥ 0.5 log10 IU/mL decline in serum HBsAg titers from baseline
time frame: Baseline, Weeks 12, 24, and 48
Proportions of participants with hepatitis B virus (HBV) DNA < lower limit of quantitation (LLOQ) at Weeks 24 and 48
time frame: Weeks 24 and 48
Proportion of subject experiencing virologic breakthrough
time frame: Up to Week 12
Proportion of participant with drug resistance mutations
time frame: Up to Week 48
Pharmacokinetic (PK) Parameter: AUClast of GS-9620
time frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
PK Parameter: AUCinf of GS-9620
time frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
PK Parameter: %AUCexp of GS-9620
time frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
PK Parameter: Cmax of GS-9620
time frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
PK Parameter: Clast of GS-9620
time frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
PK Parameter: Tmax of GS-9620
time frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
PK Parameter: Tlast of GS-9620
time frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
PK Parameter: T1/2 of GS-9620
time frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
PK Parameter: CL/F of GS-9620
time frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Adult males or females between the ages of 18-65 - Chronic HBV infection - HBV DNA ≥ 2000 IU/mL at screening 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

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 August 2016.
Information provided to ClinicalTrials.gov by Gilead Sciences.