NCT07246889

Study of AHB-137 in Participants With Chronic Hepatitis B (CHB) Treated With Nucleos(t)Ide Analogues (NAs)(AUSHINE)

A Randomized, Double-blind, Multicenter Phase III Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With HBeAg-negative Chronic Hepatitis B Treated With Nucleos(t)Ide Analogues

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 577 (actual)
• Sponsor: Ausper Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, double-blind, multicenter phase 3 clinical trial to evaluate the efficacy and safety of AHB-137 injection in participants with HBeAg-negative CHB treated with NAs.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	AHB-137	AHB-137 will be injected weekly by subcutaneous injection. There are 2 leading doses on day 4 and day 11.
DRUG	Placebo	Placebo will be injected weekly by subcutaneous injection.Two additional doses given on day 4 and day 11.
DRUG	NA therapy	NA will be the background therapy. After stopping the AHB-137 or placebo injection, continue for another 12 weeks.

Timeline

• Start date: 2025-08-12
• Primary completion: 2027-03-01
• Completion: 2027-09-01
• First posted: 2025-11-24
• Last updated: 2025-12-23

Locations

28 sites across 1 country: China