The purpose of this study is to determine if ABI-H0731 given in combination with a standard of care (SOC) hepatitis B virus (HBV) nucleos(t)ide reverse transcriptase inhibitor (NUC) medication is safe and effective in participants with chronic hepatitis B virus infection (cHBV).
This is a Phase 2a, Multi-center, Double-blind, Placebo-controlled Study Evaluating ABI-H0731 as Adjunctive Therapy in Virally-suppressed Participants with cHBV.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
73
Cedars-Sinai Medical Center
Beverly Hills, California, United States
Change in Mean log10 Serum HBsAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC
Time frame: Baseline to Week 24
Change in Mean log10 Serum HBeAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC
Time frame: Baseline to Week 24
Number of Participants With 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 + NUC Therapy as Compared With Placebo + NUC Therapy
Abnormal ALT was defined as ≥1.25 x upper limit of normal (34 Units/L for female and 43 Units/L for male participants).
Time frame: Baseline to Week 24
Trough Levels of ABI-H0731 on ABI-H0731 + SOC NUC Therapy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Southern California Research Center
Coronado, California, United States
Asia Pacific Liver Center
Los Angeles, California, United States
University of California Los Angeles
Los Angeles, California, United States
Research and Education
San Diego, California, United States
Medical Associates Research Group
San Diego, California, United States
Quest Clinical Research
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
University of Miami Hospital and Clinics
Miami, Florida, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
...and 11 more locations
Time frame: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24
Trough Levels of Entecavir (ETV) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
Time frame: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24
Trough Levels of Tenofovir Alafenamide (TAF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
Time frame: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24
Trough Levels of Tenofovir Disoproxil Fumarate (TDF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC 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 + SOC NUC Therapy
Time frame: Baseline, Weeks 2, 4, 12, and 24
Trough to Peak Ratios of SOC NUC on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
Time frame: Baseline, Weeks 2, 4, 12, and 24