This Phase 2a study will assess the safety, antiviral activity, and pharmacokinetics (PK) of ABI-H2158 administered once daily for up to 72 weeks in combination with entecavir (ETV) in participants with chronic hepatitis B virus (HBV) infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
88
3 X 100 mg tablets for oral administration
Sugar pill manufactured to mimic the ABI-H2158 tablets
0.5 mg tablet for oral administration
Percentage of Participants With Adverse Events
Describes the number of participants with One or More Adverse Events while they were on treatment with the study drug.
Time frame: Up to 72 weeks
Percentage of Participants With Premature Treatment Discontinuation
Describes the number of participants who discontinued treatment with ABI-H2158/placebo prematurely.
Time frame: Up to 72 weeks
Change From Baseline in Mean log10 HBV DNA
HBV DNA was measured by Cobas AmpliPrep/ Cobas TaqMan HBV Test v2.0 (LOD 10 IU/mL). The analysis of data was descriptive only.
Time frame: Baseline and Week 24
Percentage of Participants With Abnormal Laboratory Results
Severity grades were defined by Grading Scale for Severity of Adverse Events and Laboratory Abnormalities \[The DAIDS Version 2.1\]. For maximum postbaseline toxicity grade, the most severe graded abnormality from all tests was counted for each participant. For each individual laboratory test, the most severe graded abnormality for that test was counted for a participant. A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and including the date of last dose of ABI-H2158/Placebo plus 28 days.
Time frame: Up to 72 weeks
Trough Plasma Concentration of ABI-H2158
Time frame: Predose on Day 1, Week 4, Week 48, and Week 72
Trough-to-Peak Plasma Concentration Ratio of ABI-H2158
Time frame: Predose on Day 1 and Weeks 4, 48, and 72 and at pre-specified intervals after dosing on Day 1 and Weeks 2, 8, 12, 16, 20, 24, and 28
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Coalition of Inclusive Medicine
Los Angeles, California, United States
California Liver Research Institute
Pasadena, California, United States
Stanford University Medical Center
Redwood City, California, United States
Research and Education Inc.
San Diego, California, United States
Quest Clinical Research
San Francisco, California, United States
University of Miami/Schiff Center for Liver Diseases
Miami, Florida, United States
Johns Hopkins University
Baltimore, Maryland, United States
New Discovery, LLC
Flushing, New York, United States
Northwell Health Center for Liver Disease
Manhasset, New York, United States
NYU Langone Health
New York, New York, United States
...and 34 more locations
Trough Plasma Concentration of ETV
Time frame: Predose on Day 1, Week 4, Week 48, and Week 72
Trough-to-Peak Plasma Concentration Ratio of ETV
Time frame: Predose on Day 1 and Weeks 4, 48, and 72 and at pre-specified intervals after dosing on Day 1 and Weeks 2, 8, 12, 16, 20, 24, and 28
Change in Mean log10 HBV pgRNA From Baseline to Week 24 and at Each Timepoint for ABI-H2158+ETV and PBO+ETV
Time frame: up to Week 72
Number of Participants With Reduction in HBV DNA Below the Assay Lower Limit of Quantitation
Time frame: Up to 72 weeks
Number of Participants With Reduction in HBV pgRNA Below the Assay Lower Limit of Quantitation
Time frame: Up to 72 weeks
Change From Baseline in Serum HBV Surface Antigen (HBsAg)
Time frame: Baseline and up to 72 weeks
Change From Baseline in Serum HBV "e" Antigen (HBeAg)
Time frame: Baseline and up to 72 weeks
Change From Baseline in Serum HBV Core-related Antigen (HBcrAg)
Time frame: Baseline and up to 72 weeks
Proportion of Subjects With Abnormal ALT at Baseline Who Have Normal ALT at Week 24 and at Each Timepoint on ABI-H2158+ETV and PBO+ETV
Time frame: Baseline and up to Week 24
Ncidence of HBV Variants With Reduced Susceptibility to ABI-H2158
Time frame: Up to 72 weeks
Change in Mean log10 HBV DNA for ABI-H2158+ETV and PBO+ETV at Each Timepoint
Time frame: up to 72 weeks