This study will explore the safety and antiviral activity of ABI-H0731 when added to a nucleos(t)ide reverse transcriptase inhibitor (NrtI) in participants who are partially virologically suppressed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
2
Asia Pacific Liver Center
Los Angeles, California, United States
California Liver Research Institute
Pasadena, California, United States
Research and Education
San Diego, California, United States
Number of Participants With an Adverse Event
Time frame: Baseline and up to 5 months
Number of Participants With Premature Discontinuation of Treatment
Time frame: Baseline and up to 5 months
Number of Participants With a Laboratory Abnormality
Time frame: Baseline and up to 5 months
Number of Participants With HBV DNA <Lower Limit of Quantification (LLOQ) at Week 48
Time frame: Week 48
Mean Change From Baseline in log10 HBV DNA
Time frame: Baseline and up to 5 months
Number of Participants With HBV DNA <LLOQ at Each Timepoint
Time frame: Baseline and up to 5 months
Number of Participants With HBV DNA <Limit of Detection (LOD)
Time frame: Baseline and up to 5 months
Mean Change From Baseline in log10 HBV Pregenomic RNA (pgRNA)
Time frame: Baseline and up to 5 months
Number of Participants With HBV pgRNA <LLOQ
Time frame: Baseline and up to 5 months
Mean Change From Baseline in log10 Serum Hepatitis B 'e' Antigen (HBeAg)
Time frame: Baseline and up to 5 months
Mean Change From Baseline in log10 Serum Hepatitis B Core-related Antigen (HBcrAg)
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Quest Clinical Research
San Francisco, California, United States
Schiff Center for Liver Disease
Miami, Florida, United States
Institute of Human Virology
Baltimore, Maryland, United States
Infectious Disease Care
Hillsborough, New Jersey, United States
Northwell Health
Manhasset, New York, United States
Office of X.M., MD
Philadelphia, Pennsylvania, United States
Prince of Wales Hospital
Hong Kong, Hong Kong
...and 2 more locations
Time frame: Baseline and up to 5 months
Mean Change From Baseline in log10 Serum Hepatitis B Surface Antigen (HBsAg)
Time frame: Baseline and up to 5 months
Number of Participants With Normalized Alanine Aminotransferase (ALT)
Time frame: Baseline and up to 5 months
Plasma Concentrations of ABI-H0731
Time frame: Baseline and up to 5 months
Plasma Concentrations of Entecavir
Time frame: Baseline and up to 5 months
Incidence of HBV Variants Among Participants With Evidence of Non-response to Treatment
Time frame: Baseline and up to 5 months