Status:
ACTIVE_NOT_RECRUITING
Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB).
Lead Sponsor:
Ausper Biopharma Co., Ltd.
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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. The total duration of the study, including screening phase, treatment phase and follow-up phase.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- 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.;
- Participants with severe infection requiring intravenous anti-infection treatment 1 month before randomization;
- Active hepatitis C, Human immunodeficiency virus (HIV) positive, syphilis positive;
- Liver stiffness measurement (LSM) \> 9.0 kPa when screening;
- Diagnosed or suspected hepatocellular carcinoma;
- The laboratory examination results are obviously abnormal;
- History of vasculitis or signs and symptoms of potential vasculitis;
- History of extrahepatic disease that may be related to HBV immune status;
- 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;
- 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;
- 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;
- Any other circumstances or conditions for which the investigator considers that the participants are inappropriate to participate in the study.
Key Trial Info
Start Date :
July 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2026
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT06550128
Start Date
July 10 2024
End Date
June 30 2026
Last Update
November 26 2025
Active Locations (6)
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1
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
2
The third People's Hospital of Zhenjiang
Zhenjiang, Jiangsu, China
3
Beijing Friendship Hospital, Capital Medical University
Beijing, China
4
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China