A Study to Evaluate AHB-137 Injection in Treatment-naïve Participants With Chronic Hepatitis B

Официальное название

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2 Clinical Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Treatment-naïve Participants With Chronic Hepatitis B.

Обзор

This study is a randomized, double-blind, placebo-controlled, multicenter phase 2 study to assess the efficacy and safety of AHB-137 injection in treatment-naïve participants with chronic hepatitis B.

Вмешательства

• Препарат AHB-137
  AHB-137 will be administered subcutaneously.
• Препарат Placebo
  Placebo will be administered subcutaneously.

Первичные конечные точки

• HBV DNA < lower limit of quantitation (LLOQ), 10 IU/mL, HBsAg < limit of detection (LOD), 0.05 IU/mL with or without hepatitis B virus surface antibody (HBsAb) 24 weeks after discontinuation of all chronic hepatitis B treatment. [Срок оценки: Up to 48 weeks.]
• Highly sensitive HBsAg < 0.005 IU/mL and HBV DNA < LLOQ (10 IU/mL) at the end of treatment. [Срок оценки: Up to 48 weeks.]

Вторичные конечные точки (12)

• HBV DNA < LLOQ, 10 IU/mL, and HBsAg < 10 IU/mL 24 weeks after discontinuation of all chronic hepatitis B treatment. [Срок оценки: Up to 48 weeks.]
• HBV DNA < LLOQ 24 weeks after discontinuation of all chronic hepatitis B treatment. [Срок оценки: Up to 48 weeks.]
• HBV DNA < LLOQ and HBsAg < 100 IU/mL 24 weeks after discontinuation of all chronic hepatitis B treatment. [Срок оценки: Up to 48 weeks.]
• HBsAg seroconversion rate 24 weeks after discontinuation of all chronic hepatitis B treatment. [Срок оценки: Up to 48 weeks.]
• HBeAg seroconversion rate 24 weeks after discontinuation of all chronic hepatitis B treatment. [Срок оценки: Up to 48 weeks.]
• Proportion of participants who discontinued all chronic hepatitis B treatment at the end of treatment. [Срок оценки: Up to 48 weeks.]
• HBV DNA < LLOQ and HBsAg < LOD rate and HBV DNA < LLOQ and HBsAg < 10 IU/mL rate by visit. [Срок оценки: Up to 48 weeks.]
• HBsAg, HBeAg seroconversion rates by visit. [Срок оценки: Up to 48 weeks.]
• Test Values of Virological Parameters. [Срок оценки: Up to 48 weeks.]
• Time to first achievement of HBsAg and first HBeAg seroconversion. [Срок оценки: Up to 48 weeks.]
• Changes of the hepatitis B quality of life (HBQOL) instrument in participants compared with baseline. [Срок оценки: Up to 48 weeks.]
• Changes of the score of EuroQol Five-Dimension Five-Level Scale (EQ-5D-5L) in participants compared with baseline. [Срок оценки: Up to 48 weeks.]

Критерии участия

Критерии включения

• Volunteer to participate and sign the informed consent form, and are willing to complete the study in accordance with the requirements of the protocol.
• Aged 18-65 years (including boundary values).
• Body mass index between the range of 18-32 kg/m2 (inclusive boundary values).
• HBsAg or HBV DNA positive for ≥ 6 months at screening and no antiviral treatment with interferon or nucleoside analogue.
• HBsAg and HBV DNA values met protocol requirements at screening.
• ALT < 3xULN at screening.
• Use highly effective contraception as required.

Критерии исключения

• Uncontrolled and stable clinically significant abnormalities other than a history of chronic HBV infection.
• Participants with other clinically significant liver diseases, previous/current manifestations of hepatic decompensation, and a history of extrahepatic diseases that may be related to HBV immune status.
• Any serious infection other than chronic hepatitis B infection requiring intravenous anti-infective therapy within 1 month prior to randomization.
• Hepatitis C virus (HCV) infection or < 12 months from cure at screening (HCV RNA positive within 12 months), human immunodeficiency virus (HIV) positive at screening, and syphilis positive (treponema pallidum antibody positive).
• Significant fibrosis or cirrhosis, or liver stiffness value (LSM) > 9.0 kPa at screening.
• Participants with confirmed or suspected liver cancer who have a history of malignancy within the past 5 years or are undergoing assessment for a possible malignancy.
• Laboratory test results do not meet the criteria.
• Prior/current autoimmune disease, history of vasculitis, or presence of signs, symptoms, or laboratory tests of underlying vasculitis.
• Fridericia ' s formula corrected QT interval (QTcF) ≥ 450 msec for male participants and ≥ 470 msec for female participants at screening.
• Allergic to AHB-137 ingredients, or history of drug allergy or other allergies.
• Major trauma or major surgery within 3 months prior to screening, or planned surgery during the trial.
• Participants are participating in another clinical trial or failing to wash out as required.
• Current use or use of any immunosuppressive medication (e.g. prednisone) within 3 months prior to screening, except for short courses (≤ 2 weeks) or use of topical/inhaled steroids;Those who have used immunomodulators within 3 months prior to screening;Those who have used cytotoxic drugs within 6 months prior to screening;History of vaccination within 1 month prior to screening or a live vaccination plan during the trial.
• Participants that require regular long-term anticoagulants.
• Abnormal thyroid function.
• Participants that have received any antisense oligonucleic acid, siRNA, capsid assembly modulator (CAM) antiviral drug used to treat chronic hepatitis B.
• Any other circumstances or conditions in which, in the opinion of the investigator, the participant is inappropriate for participation in this trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 34 центра

• AusperBio Investigational Site — Пекин
• AusperBio Investigational Site — Чунцин
• The Second Affiliated Hospital of Chongqing Medical University — Чунцин
• AusperBio Investigational Site — Xiamen
• AusperBio Investigational Site — Гуанчжоу
• AusperBio Investigational Site — Гуанчжоу
• AusperBio Investigational Site — Гуанчжоу
• AusperBio Investigational Site — Jiangmen
• … и ещё 26 центров

Идентификаторы

NCT: NCT07635186 · AB-10-8016

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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