NCT06550128CompletedPhase 2
Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB).
Randomized, Multi-center Phase II Study to Evaluate the Efficacy and Safety of AHB-137 in HBeAg-negative CHB Subjects Under Stable Nucleos(t)Ide Analogue (NA) Treatment
Source: ClinicalTrials.gov · Last updated 15 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 86 (actual)
- First submitted
- 5 Aug 2024
- Start date
- 10 Jul 2024
- Primary completion date
- 26 May 2025
- Lead sponsor
- Ausper Biopharma Co., Ltd.
- Diseases
- Hepatitis B
- NCT number
- NCT06550128
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 86
- From 10 Jul 2024 to the primary completion date, 26 May 2025
- 6 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
- Clinical significant abnormalities except Chronic HBV infection, such as acute coronary syndrome within 6 months before screening, evidence of major surgery, major or unstable heart disease, bleeding tendency or significant coagulation disorder within 3 months before screening;
- Participants with severe infection requiring intravenous anti-infection treatment 1 month before randomization;
- Administration of immunosuppressants within 3 months prior to screening, except for short-term use (≤2 weeks) or topical/inhaled steroids. Administration of immunomodulators (thymosin) and cytotoxic drugs within 6 months prior to the first study intervention or have a history of vaccination within 1 month prior to screening or planned administration during the study.
- Administration of any Interferon within 6 months prior to screening;
- Participants who have significant trauma or major surgery within 3 months before screening, or plan to perform surgery during the study;
- Blood donation or blood loss more than 400 mL within 12 weeks before screening; Blood transfusion; Blood donation or blood loss not less than 200 mL within 1 month before screening;
- Concurrently participating in another clinical study, or received an investigational product within the following time period prior to the first dosing day in the current study: 5 half-lives or twice the duration of the biological effect of the study treatment or 90 days;
- Any oligonucleotide or siRNA treatments within 12 months prior to first dosing;
Other illness
- Any clinically significant liver diseases, including but not limited to hepatitis caused by other pathogenic infections, hemochromatosis, Wilson disease, primary biliary cirrhosis, autoimmune liver diseases, alcoholic liver disease, severe non-alcoholic fatty liver disease, Drug-induced liver injury, etc.;
- Active hepatitis C, Human immunodeficiency virus (HIV) positive, syphilis positive;
- History of vasculitis or signs and symptoms of potential vasculitis;
- History of extrahepatic disease that may be related to HBV immune status;
- History of malignant tumor within the past 5 years;
- Any suspicion of drug component allergy, or allergic constitution (various drug and food allergy, and judged by the investigator to be clinically significant) in participants;
- Any other circumstances or conditions for which the investigator considers that the participants are inappropriate to participate in the study.
Lab values
- The laboratory examination results are obviously abnormal;
Other
- Liver stiffness measurement (LSM) \> 9.0 kPa when screening;
- Diagnosed or suspected hepatocellular carcinoma;
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 and discontinue their NA therapy according to the protocol;
- At least 18 years old at the time of signing of the informed consent;
- Body Mass Index (BMI) between 18 to 32 kg/m\^2(inclusive) ;
- Participants who are Hepatitis B envelop antigen (HBeAg) negative during screening;
- Participants whose serum HBsAg positive for at least 6 months prior to screening;
- Participants who have stable on NA therapy at least 6 months prior to screening;
- Participants with HBsAg concentration \>100 IU/mL and≤3000 IU/mL, HBV DNA\<100 IU/mL;
- Participants with alanine aminotransferase (ALT)≤ 2x upper limit of normal (ULN);
- For women of childbearing potential, she should be non-pregnant or non-lactating during screening, and participants (and partners) are willing to take effective contraceptive measures from the screening until the last visit or at least 6 months after the last dosing.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The Second Affiliated Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Mengchao Hepatobiliary Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Jilin City | China | Unknown status |
| The Third People's Hospital of Zhenjiang Coordinator of this site? Confirm its status | Zhenjiang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.