NCT07246889Active, not recruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 4 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 577 (actual)
- First submitted
- 12 Aug 2025
- Start date
- 12 Aug 2025
- Primary completion date
- 18 Dec 2026
- Lead sponsor
- Ausper Biopharma Co., Ltd.
- Diseases
- Hepatitis B
- NCT number
- NCT07246889
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 577
- From 12 Aug 2025 to the primary completion date, 18 Dec 2026
- 28 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant clinically significant other liver diseases;
- Previous/current manifestations of hepatic decompensation;
- 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;
Other illness
- Clinically significant abnormalities other than a history of chronic HBV infection;
- History of malignancy or ongoing assessment of possible malignancy;
- Those allergic to AHB-137 or its components;
Lab values
- Presence of protocol-specified laboratory abnormalities;
Other
- Significant hepatic fibrosis or cirrhosis;
- Inappropriate for participation in this trial as judged by the investigator.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (28)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.