Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 10:59 AM
Study NCT ID:
NCT04398134
Status:
TERMINATED
Last Update Posted:
2022-09-15
First Post:
2020-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of ABI-H2158-containing Regimens in Participants With Chronic Hepatitis B Virus Infection
Sponsor:
Assembly Biosciences
Organization:
Study Overview
Official Title:
A Phase 2a, Multicenter, Single-Blind, Placebo-Controlled, Multiple Cohort Study Evaluating ABI-H2158-Containing Regimens in Chronic Hepatitis B Infection
Status:
TERMINATED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study stopped due to a safety signal of drug-induced liver injury in subjects receiving 2158
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2019-004902-85 | EUDRACT_NUMBER | None | View |