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

Ausper Biopharma

Status and phase

Active, not recruiting

Phase 3

Conditions

Chronic Hepatitis B

Treatments

Drug: NA therapy

Drug: Placebo

Drug: AHB-137

Study type

Interventional

Funder types

Industry

Identifiers

NCT07246889

AB-10-8006

Details and patient eligibility

About

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.

Enrollment

577 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participants voluntarily participate in the study, and sign the Informed Consent Form (ICF) prior to screening, able to complete the study according to the protocol;
At least 18 years of age at the time of signing the ICF;
Body mass index met the requirements;
HBeAg negative at screening;
HBsAg or HBV DNA positive for at least 6 months;
Meet relevant requirements for NAs treatment;
100 IU/mL < HBsAg ≤ 3000 IU/mL, HBV DNA < 100 IU/mL and liver function indicators meet the requirements;
Effective contraception as required.

Exclusion criteria

Clinically significant abnormalities other than a history of chronic HBV infection;
Concomitant clinically significant other liver diseases;
Previous/current manifestations of hepatic decompensation;
Significant hepatic fibrosis or cirrhosis;
Presence of protocol-specified laboratory abnormalities;
History of malignancy or ongoing assessment of possible malignancy;
Those allergic to AHB-137 or its components;
Participants with recent major trauma or major surgery, or planning surgery;
Those who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study;
Prior/current use of prohibited medications;
Inappropriate for participation in this trial as judged by the investigator.