The primary objectives of this study are to evaluate the safety, tolerability and antiviral activity of selgantolimod (formerly GS-9688) in virally suppressed chronic hepatitis B (CHB) adults on oral antiviral (OAV) agents.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Tablet(s) administered orally once weekly
Placebo to match (PTM) selgantolimod tablet(s) administered orally once weekly
Commercially available HBV OAV therapy could include one of the following: Tenofovir disoproxil fumarate (TDF; Viread®) Entecavir (Baraclude®) Adefovir (Hepsera®) Lamivudine (Epivir® ) Telbivudine (Tyzeka®) Tenofovir alafenamide (TAF; Vemlidy®)
University of Maryland, Institute of Human Virology
Baltimore, Maryland, United States
Auckland Clinical Studies Limited
Auckland, New Zealand
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum Quantitative Hepatitis B Surface Antigen (qHBsAg) From Baseline at Week 24
Time frame: Week 24
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 4
Time frame: Week 4
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 8
Time frame: Week 8
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 12
Time frame: Week 12
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 48
Time frame: Week 48
Change From Baseline in Serum qHBsAg at Week 4
Time frame: Baseline, Week 4
Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 8
Time frame: Baseline, Week 8
Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 48
Time frame: Baseline, Week 48
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Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12
HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit.
Time frame: Week 12
Percentage of Participants With HBsAg Loss at Week 24
HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit.
Time frame: Week 24
Percentage of Participants With HBsAg Loss at Week 48
HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit.
Time frame: Week 48
Percentage of Participants With HBeAg Loss and Seroconversion at Week 12
HBeAg loss was defined as qualitative HBeAg changing from positive at baseline to negative at a postbaseline visit. HBeAg seroconversion was defined as HBeAb test changing from negative or missing at baseline to positive at a postbaseline visit.
Time frame: Week 12
Percentage of Participants With HBeAg Loss and Seroconversion at Week 24
HBeAg loss was defined as qualitative HBeAg changing from positive at baseline to negative at a postbaseline visit. HBeAg seroconversion was defined as HBeAb test changing from negative or missing at baseline to positive at a postbaseline visit.
Time frame: Week 24
Percentage of Participants With HBeAg Loss and Seroconversion at Week 48
HBeAg loss was defined as qualitative HBeAg changing from positive at baseline to negative at a postbaseline visit. HBeAg seroconversion was defined as hepatitis B e antibody (HBeAb) test changing from negative or missing at baseline to positive at a postbaseline visit.
Time frame: Week 48
Percentage of Participants With Virologic Breakthrough
Virologic breakthrough was defined as having two consecutive visits of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) ≥ 69 IU/mL.
Time frame: Baseline up to Week 48
Percentage of Participants With Drug Resistance Mutations
The criteria for a drug resistance mutation was having two consecutive visits of HBV DNA ≥ 69 IU/mL.
Time frame: Baseline up to Week 48