Active — Not RecruitingPhase 2

Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB).

China86 participantsStarted 2024-07-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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);

Exclusion criteria

✕. 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;

What they're measuring

Proportion of participants achieving HBsAg < limit of detection (LOD) 0.05 International Unit/mL (IU/mL) and HBV DNA < lower limit of quantitation (LLOQ) with or without anti-HBs seroconversion at the end of treatment.

Timeframe: Up to 24 weeks

Trial details

NCT IDNCT06550128

SponsorAusper Biopharma Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-26

View on ClinicalTrials.gov More Hepatitis B, Chronic trials