Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06550128
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Subjects With Chronic Hepatitis B CHB
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Multi-center Phase II Study to Evaluate the Efficacy and Safety of AHB-137 in HBeAg-negative CHB Subjects Under Stable NucleostIde Analogue NA Treatment
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
AB-10-8003 is a randomized multi-center phase II study to evaluate the efficacy and safety of AHB-137 in subjects with HBeAg-negative CHB under stable NA treatment
Detailed Description:
The study is to evaluate the efficacy and safety of AHB-137 in HBeAg-negative CHB subjects About 60 subjects will be recruited and randomly divided into two cohorts The total duration of the study including screening phase up to 28 days AHB-137 ON treatment phase up to 24 weeks AHB-137 OFF treatment phase 24 weeks and follow-up phase 24 weeks Cohort A will be treated with AHB-137 for 24 weeks during the AHB-137 ON treatment phase while Cohort B will be administered with placebo for the first 8 weeks followed by AHB-137 dosing for 16 weeks during the AHB-137 ON treatment phase
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None