Trials / Terminated
TerminatedNCT04454567
A Study Evaluating Treatment Intensification With ABI-H0731 in Participants With Chronic Hepatitis B Infection on Nucleos(t)Ide Reverse Transcriptase Inhibitors
A Phase 2a, Multi-Center, Single-Blind, Placebo-Controlled Study Evaluating Treatment Intensification With ABI-H0731 in Subjects With Chronic Hepatitis B Infection on Nucleos(t)Ide Reverse Transcriptase Inhibitors
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- Assembly Biosciences · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ABI-H0731 | Participants will receive ABI-H0731 tablets orally once daily |
| DRUG | Placebo | Participants will receive placebo to ABI-H0731 tablets orally once daily |
| DRUG | NrtI | Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert |
Timeline
- Start date
- 2020-11-11
- Primary completion
- 2021-04-08
- Completion
- 2021-04-08
- First posted
- 2020-07-01
- Last updated
- 2022-10-20
- Results posted
- 2022-10-20
Locations
12 sites across 3 countries: United States, Hong Kong, New Zealand
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04454567. Inclusion in this directory is not an endorsement.