Chronic hepatitis B
Conditions
Interventions
Control group:A weekly subcutaneous injection of the placebo of AHB-137 injection at a dose of 300mg was administered on days 4 and 11, and the corresponding loadin.
Experimental group:Subcutaneous injection of 300 mg of AHB-137 solution once weekly, with corresponding loading doses administered on D4 and D11, treated until week 24.
Sponsors
The 2nd Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Participants who voluntarily participate in this trial and have signed the informed consent form before participating in the trial, agreeing to complete the trial process as per the trial protocol, and who are willing and able to receive or terminate treatment in accordance with the protocol; 2. Individuals aged between 18 and 65 years old (inclusive of both boundaries) when signing the informed consent form; 3. Individuals with a body mass index (BMI) within the range of 18 - 32 kg/m^2 (including the boundary values, BMI = weight (kg) / height^2 (m^2)) - for men, weight >= 50 kg, and for women, weight >= 45 kg; 4. Those who had positive HBsAg or HBV DNA for at least 6 months during the screening period and had not received antiviral treatment with interferon or nucleoside (acid) analog drugs; 5. During the screening process, the criteria are 10 IU/mL < HBsAg <= 1500 IU/mL and 20 IU/mL < HBV DNA <= 20000 IU/mL; 6. Those with ALT less than 3 times the ULN during the screening process; 7. Those who agree to take effective contraceptive measures during participation in this trial shall comply with the following requirements: (1) Male participants shall continue to adopt the highly effective and reliable contraceptive measures as described in Appendix 1 from the time they sign the informed consent form until the last administration of the investigational drug or until the end of the study (whichever is later); (2) Female participants participating in this trial shall not be pregnant and shall not be in the lactation period, and shall meet any of the following conditions: They are women with no fertility (WONCBP), as defined in Appendix 1; They are fertile women (WOCBP), and shall have continuously adopted the highly effective contraceptive measures as described in Appendix 1 from the time they sign the informed consent form until the last administration of the investigational drug or until the end of the study (whichever is later), and agree not to donate eggs for reproductive purposes during this period.
Exclusion criteria
Exclusion criteria: 1. In addition to a history of chronic HBV infection, there are uncontrolled and clinically significant abnormalities, such as acute coronary syndrome or acute cerebrovascular disease within the previous 6 months, or evidence of unstable cardiac disease, bleeding tendency, or significant coagulation disorders within the previous 3 months before screening; 2. Patients with other clinically significant liver diseases, including but not limited to hemochromatosis, Wilson's disease, primary biliary cholangitis, autoimmune hepatitis, drug-induced liver injury, etc.; imaging examination indicating severe fatty liver or liver attenuation index >294dB/m during screening; 3. Previous/current manifestations of liver dysfunction, including but not limited to: hepatic encephalopathy, hepatorenal syndrome, esophagogastric variceal bleeding, ascites, etc; 4. Those who have experienced any severe infection other than chronic hepatitis B infection within the previous 1 month and require intravenous anti-infective treatment; 5. Individuals with hepatitis C virus (HCV) infection or less than 12 months from cure at the time of screening (with HCV RNA positive within 12 months), individuals who are HIV-positive at the time of screening, and individuals with positive syphilis (positive treponema pallidum antibody); 6. Subjects with significant liver fibrosis or cirrhosis indicated by pathology/abdominal ultrasonography during screening, or subjects with a liver stiffness measurement (LSM) >9.0 kPa during FibroScan/FibroTouch screening; 7. Those diagnosed with or suspected of having liver cancer, or those whose alpha-fetoprotein concentration is = 20 ng/mL during screening; 8. Those whose laboratory test results meet the following criteria: a. Serum albumin 1.25; d. Platelet count 1.5 x ULN, except for participants who, after review by the investigator, have benign non-conjugated hyperbilirubinemia and total bilirubin > 1.5 x ULN; f. Random urine albumin/creatinine ratio (uACR) exceeds 0.3 mg/mg (300 mg/g) and is confirmed by a second measurement. 9. Individuals who have had or currently have autoimmune diseases, have a history of vasculitis, or have signs, symptoms, or laboratory findings suggestive of potential vasculitis (such as vasculitic rashes, skin ulcers, recurrent microscopic hematuria of unknown cause, ANCA (antineutrophil cytoplasmic antibody) or ANA (antinuclear antibody) positivity judged clinically significant by the investigator, or other diseases potentially related to vasculitis such as systemic lupus erythematosus, rheumatoid arthritis, recurrent polyarthritis, polyneuropathy) ; 10. During the screening process, the QT interval corrected by the Fridericia formula (QTcF) for male participants was > 450 milliseconds, and for female participants, it was = 470 milliseconds (if the single 12-lead ECG examination result at the time of screening met the above standards, a 12-lead ECG examination needs to be repeated to confirm). 11. Individuals with a history of extrhepatic diseases that may be related to the HBV immune status (for example, nephrotic syndrome, any type of glomerulonephritis, polyarteritis nodosa, cryoglobulinemia, uncontrolled hypertension); 12. Participants who have a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical cure 24 weeks after discontinuation of all chronic hepatitis B treatments.;high-sensitivity HBsAg < 0.005 IU/mL, and HBVDNA < LLOQ (10 IU/mL); HBeAg-positive participants must simultaneously meet the requirement of HBeAg seroconversion.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma drug concentrations of AHB-137 in participants at different time points; The incidence and severity of adverse events (TEAE) and serious adverse events (SAE) during treatment;Partial cure after discontinuing all chronic hepatitis B treatments for 24 weeks.;HBsAg seroconversion rate at 24 weeks after discontinuation of all chronic hepatitis B treatments; | — |
Countries
China
Contacts
Public ContactPeng Hu
The 2nd Affiliated Hospital of Chongqing Medical University
Outcome results
None listed