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

Not Applicable

Active, not recruiting

• Conditions: Chronic Hepatitis B
• Interventions: Drug: AHB-137; Drug: Peg-IFN; Drug: Hepatitis B Vaccine

• Registration Number: NCT07069569
• Lead Sponsor: Ausper Biopharma Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-05-30
• Study First Submitted: 2025-06-25
• Study First Submitted QC: 2025-07-06
• Study First Posted: 2025-07-16
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-23
• Last Update Posted: 2025-09-26
• Primary Completion: 2027-01-01
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 127

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AHB-137 (16 weeks) and Peg-IFN	AHB-137	-
AHB-137 (16 weeks) and Peg-IFN	Peg-IFN	-
AHB-137 (24 weeks) and Peg-IFN	AHB-137	-
AHB-137 (24 weeks) and Peg-IFN	Peg-IFN	-
AHB-137 and Hepatitis B vaccine	AHB-137	-
AHB-137	AHB-137	-
AHB-137 and Hepatitis B vaccine	Hepatitis B Vaccine	-

Primary Outcome Measures

Name	Time	Method
Proportion of participants with persistent HBsAg < limit of detection (LOD) and HBV DNA < lower limit of quantification (LLOQ) at the 24th week after all treatment for CHB was discontinued.	up to 72 weeks

Secondary Outcome Measures

Name	Time	Method
Proportion of participants with persistent HBsAg < LOD and HBV DNA < LLOQ .	Up to 72 weeks
Detection of the serum concentration of HBsAg, HBsAb, HBV DNA, HBV RNA, HBcrAg, HBeAb,and HBeAg.	Up to 72 weeks
Proportion of participants who met discontinuation criteria for NAs treatment at the end of the treatment period.	Up to 48 weeks
Relapse rate after discontinuation of NAs therapy.	Up to 72 weeks
Change from baseline in alanine aminotransferase (ALT) values and time to normalization of values.	Up to 72 weeks
Relapse time after discontinuation of NAs therapy.	Up to 72 weeks
Plasma concentrations of AHB-137.	Up to 48 weeks
Serum concentrations of Peg-IFN.	Up to 48 weeks.
Safety: Number and percentage of participants with detectable anti-drug antibodies (ADA).	Up to 72 weeks
Safety: Changes of the hepatitis B quality of life (HBQOL) instrument in participants compared with baseline.	Up to 72 weeks	Response options range from 1 to 5 with higher scores indicating more severe impact .
Safety: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAE) and clinically significant examination results.	Up to 72 weeks	Examination including laboratory examination, electrocardiogram (ECG) examination.
Safety: Monitoring the score changes of Columbia Suicide Severity Scale (CSSRS) .	Up to 72 weeks.	The CSSRS is a categorical, interviewer-rated instrument that screens for suicidal ideation (five items, 0-1 each) and suicidal behavior (six items, 0-1 each); the highest positive item defines the risk level rather than a total score. For ideation items 3-5 an additional 0-5 intensity rating can be recorded. Across all items the minimum value is 0 (absent) and the maximum is 1 (present); a score of 1 on any item indicates a worse outcome and triggers escalating clinical safeguards, with any behavior item being tantamount to a suicidal event.
Safety: Monitoring the score changes of Self-Rating Depression Scale (SDS).	Up to 72 weeks.	The SDS is a 20-item, 4-point Likert self-report scale that yields a raw sum of 20-80 points, conventionally converted to a standard score of 25-100 by multiplying the raw total by 1.25. Higher standard scores denote worse outcomes: \<50 normal, 50-59 mild, 60-69 moderate, and ≥70 severe depression, with ≥70 warranting specialist evaluation and suicide-risk assessment.
Safety: Changes of the score of EuroQol Five-Dimension Five-Level Scale (EQ-5D-5L) in participants compared with baseline.	Up to 72 weeks	The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

Trial Locations

Locations (1)

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing Municipality, China