RecruitingPhase 2NCT07069569

A Multicenter Study of AHB-137 Injection Combined With Other Hepatitis B Drugs

A Randomized, Open-Label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Combination With Hepatitis B Vaccine or Pegylated Interferon α-2b (Peg-IFN) in Participants With HBeAg-Negative Chronic Hepatitis B (CHB) Treated With Nucleos(t)Ide Analogue (NAs)

Sponsor

Ausper Biopharma Co., Ltd.

Enrollment

200 participants

Start Date

Jun 8, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Hepatitis B

Summary

This is a randomized, open-label, multicenter phase II study to evaluate the efficacy and safety of AHB-137 injection in combination with other hepatitis B drugs in participants with HBeAg-negative CHB treated with NAs.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria8

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;
Aged between 18 and 65 years at the time of signing the ICF;
Body mass index (BMI) within the range of 18-30 kg/ m2;
HBeAg negative at screening;
HBsAg or HBV DNA positive for at least 6 months;
Continue antiviral therapy with a single nucleoside (t) ide analogue for more than 6 months prior to screening;
Alanine aminotransferase (ALT) ≤ 2 × upper limit of normal (ULN);
Effective contraception as required.

Exclusion Criteria23

Participants who are not eligible for treatment with Peg-IFN/recombinant hepatitis B vaccine;
Clinically significant abnormalities other than a history of chronic HBV infection;
Concomitant clinically significant other liver diseases;
Any serious infection other than chronic hepatitis B infection requiring intravenous anti-infective therapy within 1 month prior to screening;
HCV RNA positive, Human immunodeficiency virus (HIV) positive, syphilis positive;
Significant liver fibrosis or cirrhosis at screening, or a liver stiffness value (LSM) > 9.0 kPa;
Previous/current manifestations of hepatic decompensation;
Diagnosis or suspicion of hepatocellular carcinoma, or alpha-fetoprotein concentration (AFP) ≥ 20 ng/mL at screening;
Obviously abnormal laboratory test results;
History of vasculitis or presence of signs, symptoms, or laboratory tests of underlying vasculitis, and previous/current other diseases that may be related to vasculitic conditions;
QT interval corrected for heart rate (Fridericia method) abnormal;
History of extrahepatic disease possibly related to HBV immune status;
Participants with a history of malignancy within the past 5 years or who are being evaluated for a possible malignancy;
Serious mental illness or history of serious mental illness prior to screening;
Suspected history of allergy to any component of the study drug, or allergic constitution;
Major trauma or major surgery within 3 months prior to screening, or planned surgery during the study;
Those who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study;
Current use or use of any immunosuppressive medication within 3 months prior to screening, with the exception of short courses (≤ 2 weeks) or use of topical/inhaled steroids;Those who have used immunomodulators and cytotoxic drugs within 6 months prior to the first dose;Or a history of vaccination within 6 months prior to screening or a live vaccination plan during the trial;
Participants requiring regular long-term administration of anticoagulants or antiplatelet drugs;
Thyroid dysfunction;
Patients with uncontrolled epilepsy and other progressive neurological disorders;
Received any antisense oligonucleotides (ASO) or small molecule interfering ribonucleic acid (siRNA) drug;
Any other circumstance or condition that, in the opinion of the investigator, the participants are inappropriate for participation in the study.