Evaluating AHB-137 for treating chronic hepatitis B in patients with low viral load

A Randomized, Multi-center, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of AHB-137 in Treatment-naive Participants with Chronic Hepatitis B with Low Viral Load

This study is testing a new treatment called AHB-137 to see if it can help people with chronic hepatitis B who haven't had antiviral treatment before.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Ausper Biopharma Co., Ltd. (Industry-sponsored)
• Locations: 4 sites (Chongqing, Chongqing and 3 other locations)
• Trial ID: NCT06829329 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of AHB-137 in participants with chronic hepatitis B (CHB) who have not previously received antiviral treatment. Approximately 60 participants will be randomly assigned to two groups based on their HBsAg levels. The study will include a screening phase lasting up to 28 days, a treatment phase of 16 weeks, and a follow-up phase of 24 weeks, totaling about 44 weeks for each participant. The intervention involves administering AHB-137 compared to a placebo.

Who should consider this trial

Good fit: Ideal candidates are treatment-naive adults aged 18-65 with chronic hepatitis B and specific viral load criteria.

Not a fit: Patients who have previously received antiviral treatment or have severe liver dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with chronic hepatitis B, potentially improving their health outcomes.

How similar studies have performed: While there have been studies on hepatitis B treatments, the specific approach with AHB-137 is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. 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;
2. Male or female participants aged 18-65 years old (including the boundary value) at the time of signing the ICF;
3. Male participants weighed higher than 50kg and female participants weighted higher than 50 kg, Body Mass Index (BMI) between 18 to 32 kg/m\^2(inclusive);
4. Participants with positive HBsAg or HBV DNA greater than or equal to (≥) 6 months prior to screening and has not received antiviral treatment with interferon or nucleos(t)ide analogue ;
5. At screening, 20 IU/mL\<HBV DNA≤2000 IU/mL;
6. At screening, 100 IU/mL\<HBsAg≤10000 IU/mL;
7. At screening, ALT\<3×upper limit of normal (ULN);
8. For women with childbearing potential should be non-pregnant or non-lactating during screening, and participants are willing to take effective contraceptive measures from the screening until the last visit or at least 6 months after the last dosing.

Exclusion Criteria:

1. Clinically significant abnormalities except chronic HBV infection;
2. Any clinically significant liver diseases, including but not limited to hepatitis caused by other pathogenic infections, hemochromatosis, Wilson disease, primary biliary cirrhosis, autoimmune liver diseases, alcoholic liver disease, severe non-alcoholic fatty liver disease, Imaging-diagnosed moderate to severe fatty liver, drug-induced liver injury, history of hereditary liver disease, etc.;
3. Participants with severe infection requiring systemic anti-infection treatment 1 month before randomization;
4. Co-infection with current or past history of Hepatitis C virus (HCV), Human immunodeficiency virus (HIV), Hepatitis D virus (HDV).
5. Participants who have had or currently have cirrhosis or currently have progressive liver fibrosis;
6. Participants who have had or currently have hepatobiliary system tumor; Or blood alpha-fetoprotein (AFP) ≥ 20 ng/mL during screening, or the liver B-ultrasound, CT, MRI and other imaging examinations suggested the possibility of hepatobiliary system tumors;
7. The laboratory examination results are obviously abnormal;
8. History of vasculitis or signs and symptoms of potential vasculitis;
9. Anti-neutrophil cytoplasmic antibodies (ANCA) was positive at screening.
10. History of extrahepatic disease that may be related to HBV immune status;
11. Administration of immunosuppressants within 3 months prior to screening, except for short-term use (≤2 weeks) or topical/inhaled steroids. Administration of immunomodulators (thymosin) and cytotoxic drugs within 6 months prior to the first study intervention or have a history of vaccination within 1 month prior to screening or planned administration during the study;
12. History of malignancy within the past 5 years or the discovery of suspected tumors during the screening period;
13. Any suspicion of drug component allergy, or allergic constitution (various drug and food allergy, and judged by the investigator to be clinically significant) in participants;
14. Participants who have significant trauma or major surgery within 3 months before screening, or plan to perform surgery during the study;
15. Blood donation or blood loss more than 400 mL within 12 weeks before screening; Blood transfusion; Blood donation or blood loss not less than 200 mL within 1 month before screening;
16. Concurrently participating in another clinical study, or received an investigational product within the following time period prior to the first dosing day in the current study: 5 half-lives or twice the duration of the biological effect of the study treatment or 90 days, whichever is longer;
17. Participants who have received any oligonucleotide or small molecule interfering ribonucleic acid (siRNA) drugs;
18. Any other circumstances or conditions for which the investigator considers that the participants are inappropriate to participate in the study.

Where this trial is running

Chongqing, Chongqing and 3 other locations

• The Second Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing, China (Recruiting)
• Mengchao Hepatobiliary Hospital of Fujian Medical University — Fuzhou, Fujian, China (Recruiting)
• The Third People's Hospital of Zhenjiang — Zhenjiang, Jiangsu, China (Recruiting)
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Bella Lu

Conditions Chronic Hepatitis B; Hepatitis B, Chronic