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

NCT07069569 | Active Not Recruiting Phase 2

• 1 other identifier: AB-10-8007
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis B

Keywords

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• 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

Study Arms (4)

AHB-137 (16 weeks) and Peg-IFN

EXPERIMENTAL

Drug: AHB-137; Drug: Peg-IFN

AHB-137 (24 weeks) and Peg-IFN

EXPERIMENTAL

Drug: AHB-137; Drug: Peg-IFN

AHB-137 and Hepatitis B vaccine

EXPERIMENTAL

Drug: AHB-137; Drug: Hepatitis B Vaccine

AHB-137

EXPERIMENTAL

Drug: AHB-137

Interventions

AHB-137 DRUG

AHB-137 will be injected.

AHB-137; AHB-137 (16 weeks) and Peg-IFN; AHB-137 (24 weeks) and Peg-IFN; AHB-137 and Hepatitis B vaccine

Peg-IFN DRUG

Peg-IFN will be administered .

AHB-137 (16 weeks) and Peg-IFN; AHB-137 (24 weeks) and Peg-IFN

Hepatitis B Vaccine DRUG

Hepatitis B vaccine will be administered.

AHB-137 and Hepatitis B vaccine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;

Sponsors & Collaborators

• Ausper Biopharma Co., Ltd.: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Hepatitis B Vaccines

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Jia

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 16, 2025
• Study Start: May 30, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)