A Multicenter Study of AHB-137 Injection Combined With Other Hepatitis B Drugs
Recruiting now · Phase 2
Conditions studied: Chronic Hepatitis B
In brief
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.
Key facts
- Study ID
- NCT07069569
- Run by
- Ausper Biopharma Co., Ltd.
- People needed
- 200
- Starts
- 2025-06-08
- Expected to finish
- 2028-01-15
- Last updated by the study team
- 2026-07-29
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- AusperBio Investigational Site — Chongqing, Chongqing Municipality, China (enrolling)
- AusperBio Investigational Site — Fuzhou, Fujian, China (enrolling)
- AusperBio Investigational Site — Guangzhou, Guangdong, China (enrolling)
- AusperBio Investigational Site — Guangzhou, Guangdong, China (enrolling)
- AusperBio Investigational Site — Shenzhen, Guangdong, China (enrolling)
- AusperBio Investigational Site — Shenzhen, Guangdong, China (enrolling)
- AusperBio Investigational Site — Zunyi, Guizhou, China (enrolling)
- AusperBio Investigational Site — Wuhan, Hubei, China (enrolling)
- AusperBio Investigational Site — Changchun, Jilin, China (enrolling)
- AusperBio Investigational Site — Chengdu, Sichuan, China (enrolling)
- AusperBio Investigational Site — Chengdu, Sichuan, China (enrolling)
- AusperBio Investigational Site — Kunming, Yunnan, China (enrolling)
- AusperBio Investigational Site — Hangzhou, Zhejiang, China (enrolling)
- Beijing Friendship Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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