The purpose of this study is to determine if ABI-H0731 given in combination with a standard of care (SOC) entecavir (ETV) is safe and effective in participants with chronic hepatitis B infection (cHBV)
This is a Phase 2a, multi-center, double-blind, placebo-controlled study evaluating ABI-H0731+ ETV vs ETV alone for the treatment of viremic hepatitis B "e" antigen (HBeAg)-positive participants with cHBV.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
25
Southern California Research Center
Coronado, California, United States
Asia Pacific Liver Center
Los Angeles, California, United States
Research and Education
San Diego, California, United States
Change in Mean log10 HBV DNA From Baseline (Day 1) to Week 12 or Week 24 on ABI H0731 + SOC ETV as Compared to Placebo + SOC ETV
Hepatitis B virus (HBV) DNA was measured using COBAS TaqMan Version 2.0. The lower limit of quantitation (LLOQ) was 20 IU/mL and the limit of detection (LOD) was 10 IU/mL.
Time frame: Baseline, Week 12, and Week 24
Number of Participants One or More Adverse Events
Time frame: Up to Follow-up (maximum up to Week 36)
Number of Participants With Premature Study Discontinuation
Time frame: Up to Follow-up (maximum up to Week 36)
Number of Participants With One or More Abnormal Safety Laboratory Result
Time frame: Up to Week 36
Number of Participants With a Clinically-significant Electrocardiogram Abnormality
Time frame: Up to Week 24
Number of Participants With a Clinically-significant Change in Vital Signs
Vital signs assessed were body temperature, respiratory rate, and pulse rate
Time frame: Baseline and up to Week 24
Number of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at Week 24 on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV
Time frame: Baseline to Week 24
Number of Participants With a Decline in Viral DNA to Below Limit of Quantitation on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV
HBV DNA was measured using COBAS TaqMan Version 2.0. The LLOQ was 20 IU/mL and the LOD was 10 IU/mL. The number of participants with HBV DNA below the limit of quantitation (\<20 IU/mL) and target detected (≥10 IU/mL) was assessed.
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Quest Clinical Research
San Francisco, California, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
NYU Langone Health
New York, New York, United States
Xiaoli Ma MD
Philadelphia, Pennsylvania, United States
GI Research Institute
Vancouver, British Columbia, Canada
Toronto Liver Center
Toronto, Ontario, Canada
University of Hong Kong, Queen Mary Hospital
Hong Kong, Hong Kong
...and 2 more locations
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24
Median Time to Viral Suppression, Defined as HBV DNA <20 IU/mL, on ABI-H0731 + ETV as Compared to Placebo + ETV
Median time to viral suppression will be calculated and evaluated between participants on ABI-H0731 + ETV as compared to placebo + ETV.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24
Number of Participants With Emergence of Resistant HBV Variants on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV
Emergence of a resistant HBV variant was defined as an increase of ≥1 log10 IU/mL from the nadir in HBV DNA.
Time frame: Up to Week 36
Trough Levels of ABI-H0731 on ABI-H0731 + SOC ETV Therapy
Time frame: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24
Trough Levels of ETV on ABI-H0731 + ETV Therapy as Compared With Placebo + ETV Therapy
Time frame: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24
Trough to Peak Ratios of ABI-H0731 on ABI-H0731 + ETV Therapy
Time frame: Baseline, Weeks 2, 4, 12, and 24
Trough to Peak Ratios of ETV on ABI-H0731 + ETV Therapy as Compared With Placebo + ETV Therapy
Time frame: Baseline, Weeks 2, 4, 12, 24, and 28