Tests AHB-137 with other drugs for chronic hepatitis B
Tests AHB-137 combined with vaccine or peginterferon in adults with chronic hepatitis B.
Plain-language title generated from the registry record
Registry title: A Multicenter Study of AHB-137 Injection Combined With Other Hepatitis B Drugs
Key facts
- Where
- Beijing, Changchun, Chengdu, Chongqing, Fuzhou, Guangzhou, Hangzhou, Kunming, Shenzhen, Wuhan, and Zunyi, ChinaSee the 11 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with chronic hepatitis B who test negative for HBeAg and have taken one nucleos(t)ide analogue antiviral for more than 6 months.
- Age
- 18 to 65 years
- Sex
- All sexes can join
- Disease stage
- Chronic hepatitis B, HBeAg negative. HBsAg or HBV DNA positive for at least 6 months. ALT no higher than 2 × the upper limit of normal. No significant liver scarring or cirrhosis (liver stiffness above 9.0 kPa excludes).
- Earlier treatment
- Must have taken a single nucleoside (t)ide analogue antiviral for more than 6 months before screening. Cannot have received any antisense oligonucleotide (ASO) or small interfering RNA (siRNA) drug.
- Biomarker or test result
- HBeAg negative at screening. HBsAg or HBV DNA positive for at least 6 months.
Main reasons for not taking part
- HCV RNA, HIV or syphilis positive
- Cirrhosis, liver stiffness above 9.0 kPa, or signs of liver decompensation
- Known or suspected liver cancer, or AFP of 20 ng/mL or more
- Cancer within the past 5 years
- Immunosuppressive drugs within 3 months before screening, except short courses of 2 weeks or less
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07069569, who can take part
Where in China
- Beijing Friendship Hospital, Capital Medical UniversityBeijing, ChinaTaking people
- Changchun, JilinHospital not named in the registryTaking people
- Chengdu, SichuangHospital not named in the registryTaking people
- Chongqing, Chongqing MunicipalityHospital not named in the registryTaking people
- Fuzhou, FujianHospital not named in the registryTaking people
- Guangzhou, GuangdongHospital not named in the registryTaking people
- Hangzhou, ZhejiangHospital not named in the registryTaking people
- Kunming, YunnanHospital not named in the registryTaking people
- Shenzhen, GuangdongHospital not named in the registryTaking people
- Wuhan, HubeiHospital not named in the registryTaking people
- Zunyi, GuizhouHospital not named in the registryTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Ausper Biopharma Co., Ltd.
- Trial code
- NCT07069569
- Record updated
- 29 July 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: Participants who are not eligible for treatment with Peg-IFN/recombinant hepatitis B vaccine; 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; Previous/current manifestations of hepatic decompensation; Serious mental illness or history of serious mental illness prior to screening; 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; Received any antisense oligonucleotides (ASO) or small molecule interfering ribonucleic acid (siRNA) drug; Clinically significant abnormalities other than a history of chronic HBV infection; HCV RNA positive, Human immunodeficiency virus (HIV) positive, syphilis positive; 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; Suspected history of allergy to any component of the study drug, or allergic constitution; Patients with uncontrolled epilepsy and other progressive neurological disorders; Any other circumstance or condition that, in the opinion of the investigator, the participants are inappropriate for participation in the study; 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; Significant liver fibrosis or cirrhosis at screening, or a liver stiffness value (LSM) > 9.0 kPa; Diagnosis or suspicion of hepatocellular carcinoma, or alpha-fetoprotein concentration (AFP) ≥ 20 ng/mL at screening; Thyroid dysfunction.