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Clinical Trials in China / NCT07069569
Recruiting Phase 2

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

NCT07069569 · tracked via the Priya Life Science China tracker
Sponsor
Ausper Biopharma Co., Ltd.
Phase
Phase 2
Started
2025-06-08
Last updated
2026-07-29

Condition(s) studied

Chronic Hepatitis B

Investigational drug(s) / intervention(s)

AHB-137Peg-IFNHepatitis B Vaccine

AHB-137: AHB-137 will be injected.

Peg-IFN: Peg-IFN will be administered .

Hepatitis B Vaccine: Hepatitis B vaccine will be administered.

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (14)

FacilityCityRegionStatus
Beijing Friendship Hospital, Capital Medical University Beijing Beijing Municipality Recruiting
AusperBio Investigational Site Chongqing Chongqing Municipality Recruiting
AusperBio Investigational Site Fuzhou Fujian Recruiting
AusperBio Investigational Site Guangzhou Guangdong Recruiting
AusperBio Investigational Site Guangzhou Guangdong Recruiting
AusperBio Investigational Site Shenzhen Guangdong Recruiting
AusperBio Investigational Site Shenzhen Guangdong Recruiting
AusperBio Investigational Site Zunyi Guizhou Recruiting
AusperBio Investigational Site Wuhan Hubei Recruiting
AusperBio Investigational Site Changchun Jilin Recruiting
AusperBio Investigational Site Chengdu Sichuan Recruiting
AusperBio Investigational Site Chengdu Sichuan Recruiting
AusperBio Investigational Site Kunming Yunnan Recruiting
AusperBio Investigational Site Hangzhou Zhejiang Recruiting

More Ausper Biopharma Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07069569 on ClinicalTrials.gov ↗ ← All trials in China