NCT07069569 A Multicenter Study of AHB-137 Injection Combined With Other Hepatitis B Drugs
| NCT ID | NCT07069569 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Ausper Biopharma Co., Ltd. |
| Condition | Chronic Hepatitis B |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-06-08 |
| Primary Completion | 2027-07-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2025-06-08 with a primary completion date of 2027-07-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Jia
PRINCIPAL INVESTIGATOR
Beijing Friendship Hospital
Frequently Asked Questions
Who can join the NCT07069569 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Chronic Hepatitis B. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07069569 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07069569 currently recruiting?
Yes, NCT07069569 is actively recruiting participants. Contact the research team at clinicaltrial@ausperbio.com for enrollment information.
Where is the NCT07069569 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07069569 clinical trial?
NCT07069569 is sponsored by Ausper Biopharma Co., Ltd.. The principal investigator is Jia at Beijing Friendship Hospital. The trial plans to enroll 200 participants.