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

Ausper Biopharma

Status and phase: Active, not recruiting; Phase 2

Conditions: Chronic Hepatitis B

Treatments: Drug: Hepatitis B Vaccine; Drug: Peg-IFN; Drug: AHB-137

Study type: Interventional

Funder types: Industry

Identifiers

NCT07069569

AB-10-8007

Details and patient eligibility

About

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.

Enrollment: 127 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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127 participants in 4 patient groups

AHB-137 (16 weeks) and Peg-IFN

Experimental group

Treatment:

Drug: Peg-IFN

Drug: AHB-137

AHB-137 (24 weeks) and Peg-IFN

Experimental group

Treatment:

Drug: Peg-IFN

Drug: AHB-137

AHB-137 and Hepatitis B vaccine

Experimental group

Treatment:

Drug: AHB-137

Drug: Hepatitis B Vaccine

AHB-137

Experimental group

Treatment:

Drug: AHB-137