At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 25 enrolled
Drug / intervention
ABI-H0731 +2 moredrug
Likely dose
ABI-H0731 300mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2a, Multi-center, Double-blind, Placebo-controlled Study Evaluating ABI-H0731+ Entecavir vs Entecavir Alone for the Treatment of Viremic HBeAg-positive Patients With Chronic Hepatitis B
In Brief
A Phase 2 clinical trial evaluating ABI-H0731, SOC ETV, and 1 other intervention for Chronic Hepatitis B. Completed, enrolled 25 participants across 12 sites in 5 countries.
Detailed Summary
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)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis B
CountriesCanada, Hong Kong, New Zealand, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
Enrollment StartJun 2018
First PostedJul 2018
Primary CompletionJun 2019
TodayJul 2026
First PostedJul 5, 2018
Enrollment StartJun 19, 2018
Primary CompletionJun 21, 2019
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 8.0 years ago
Interventions
ABI-H0731drug
Participants will receive 300mg QD of ABI-H0731 tablets orally.
SOC ETVdrug
Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
Placebo Oral Tabletdrug
Participants will receive matching QD placebo tablets orally.