Trials / Terminated
TerminatedNCT04398134
A Study of ABI-H2158-containing Regimens in Participants With Chronic Hepatitis B Virus Infection
A Phase 2a, Multicenter, Single-Blind, Placebo-Controlled, Multiple Cohort Study Evaluating ABI-H2158-Containing Regimens in Chronic Hepatitis B Infection
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 88 (actual)
- Sponsor
- Assembly Biosciences · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ABI-H2158 | 3 X 100 mg tablets for oral administration |
| DRUG | Placebo | Sugar pill manufactured to mimic the ABI-H2158 tablets |
| DRUG | Entecavir (ETV) | 0.5 mg tablet for oral administration |
Timeline
- Start date
- 2020-08-28
- Primary completion
- 2021-10-14
- Completion
- 2021-12-28
- First posted
- 2020-05-21
- Last updated
- 2022-09-15
- Results posted
- 2022-08-26
Locations
44 sites across 9 countries: United States, Australia, Canada, China, Hong Kong, New Zealand, South Korea, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04398134. Inclusion in this directory is not an endorsement.