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

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

Inclusion Criteria:

* 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 Criteria:

* 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.

Conditions2

Interventions3

Related trials

• A Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB) — Ausper Biopharma Co., Ltd.
• Phase 2 Study of AHB-137 in HBeAg Negative Chronic Hepatitis B (CHB) Participants in Asia Pacific Region — AusperBio Therapeutics Inc.
• A Multicenter, Randomized, Open, Parallel-designed Study to Evaluate the Efficacy and Safety of HRS-5635 Injection Alone or in Combination With Other Agents in Patients Treated for Chronic Hepatitis B — Fujian Shengdi Pharmaceutical Co., Ltd.
• A Novel Combination Therapeutic Strategy Aiming to Functional Cure for Chronic Hepatitis B Virus Infection (Sustained HBsAg Loss) (B) — The Second Affiliated Hospital of Chongqing Medical University
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