AHB-137 in combination with hepatitis B drugs for chronic hepatitis B

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, open-label trial evaluates the safety and effectiveness of AHB-137 injected alongside other hepatitis B drugs in adults with HBeAg-negative chronic hepatitis B who have been on nucleos(t)ide analogue therapy for at least 6 months. Participants are assigned to receive AHB-137 in combination with pegylated interferon and/or hepatitis B vaccine, alongside their existing treatment, to see if it improves viral control and liver safety. The study is conducted at multiple sites in China and is led by Ausper Biopharma, with Beijing Friendship Hospital as a primary site. Eligibility requires adults 18-65 with HBV DNA or HBsAg positivity, controlled ALT, and the ability to comply with the protocol; key exclusions include significant other liver disease and active infections. Primary outcomes focus on safety and potential antiviral effects over the study period.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Friendship Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• AusperBio Investigational Site
  Chongqing, Chongqing Municipality, China Recruiting
• AusperBio Investigational Site
  Fuzhou, Fujian, China Recruiting
• AusperBio Investigational Site
  Guangzhou, Guangdong, China Recruiting
• AusperBio Investigational Site
  Guangzhou, Guangdong, China Recruiting
• AusperBio Investigational Site
  Shenzhen, Guangdong, China Recruiting

Study contacts

• Principal investigator: Jia — Beijing Friendship Hospital
• Study coordinator: Lu
• Email: clinicaltrial@ausperbio.com
• Phone: 0571-86959519

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  This phase 2 trial tests whether a sequence of anti-PD-1/PD-L1 antibodies with pegylated interferon and nucleos(t)ide analogues can achieve functional cure (HBsAg loss) in adults with chronic hepatitis B.

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• GST-HG131/GST-HG141 tablets vs placebo in chronic hepatitis B

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• AHB-137 injection in people with chronic hepatitis B

  This study tests AHB-137 vs placebo in adults with chronic hepatitis B who have not yet received antiviral treatment.

  Recruiting at 34 sites Phase 2 Ausper Biopharma Co., Ltd. · Beijing, Beijing Municipality and 33 other locations · NCT07635186

• AHB-137 injection pharmacokinetics and safety in people with mild to moderate liver dysfunction and normal liver function

  This study tests how AHB-137 behaves in the body and its safety in adults with chronic hepatitis B who have mild to moderate liver problems or normal liver function.

  Recruiting Phase 1 Ausper Biopharma Co., Ltd. · Chongqing, Chongqing Municipality and 4 other locations · NCT07600788

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.