Study of AHB-171 in Chronic Hepatitis B Participants

Официальное название

An Open-label Phase II Clinical Study to Evaluate the Efficacy and Safety of AHB-171 Injection in Participants With Chronic Hepatitis B

Обзор

The study adopts an open-label, multiple-dose design and aims to evaluate the efficacy and safety of AHB-171 Injection after multiple doses in treatment-naïve (HBeAg-negative/positive) and nucleos(t)ide analogue (NA)-treated (HBeAg-negative) participants with chronic hepatitis B (CHB)

Вмешательства

• Препарат AHB-171 Injection
  Subcutaneous injection

Первичные конечные точки

• Proportion of participants with HBsAg <10 IU/mL and HBV DNA < LLOQ (10 IU/mL) [Срок оценки: Up to 90 days]

Вторичные конечные точки (12)

• Proportion of participants achieving complete response (HBsAg <0.05 IU/mL and HBV DNA < LLOQ) [Срок оценки: Up to 90 days]
• Change of HBsAg (log₁₀ IU/mL) from baseline and maximum reduction at each visit [Срок оценки: Up to 90 days]
• Proportion of participants with HBsAg decline from baseline of <0.5, ≥0.5, ≥1.0, ≥1.5, ≥2.0, ≥3.0 log₁₀ IU/mL at each visi [Срок оценки: Up to 90 days]
• Proportion of participants with HBsAg <100 IU/mL, <10 IU/mL, <1 IU/mL at each visit [Срок оценки: Up to 90 days]
• Proportion of participants achieving HBsAg clearance (HBsAg <0.05 IU/mL) at each visit [Срок оценки: Up to 90 days]
• Proportion of participants with HBV DNA < LLOQ (10 IU/mL) at each visit [Срок оценки: Up to 90 days]
• Proportion of participants achieving complete response (HBsAg <0.05 IU/mL and HBV DNA < LLOQ) at each visit [Срок оценки: Up to 90 days]
• Proportion of participants with anti-HBs seroconversion (HBsAg clearance and HBsAb >10 IU/L) at each visit [Срок оценки: Up to 90 days]
• Absolute or log change from baseline for HBsAg at each visit [Срок оценки: Up to 90 days]
• Absolute or log change from baseline for HBV RNA at each visit [Срок оценки: Up to 90 days]
• Absolute or log change from baseline for HBcrAg at each visit [Срок оценки: Up to 90 days]
• Absolute or log change from baseline for HBeAg at each visit [Срок оценки: Up to 90 days]

Критерии участия

Критерии включения

• Able to fully understand and sign the informed consent form (ICF).
• Male or female participants, aged 18-65 years (inclusive).
• Body mass index (BMI) meeting the predefined eligibility range.
• Chronic hepatitis B (CHB) participants with HBsAg or HBV DNA positivity for ≥6 months at screening.
• At screening, participants meeting predefined ranges of HBsAg, HBV DNA, and ALT according to prior nucleos(t)ide analogue (NA) treatment history (stable prior treatment or treatment-naive), and meeting corresponding prior antiviral treatment duration requirements.
• Adopt effective contraceptive measures as required

Критерии исключения

• History of any severe systemic disease or malignancy other than chronic HBV infection which, in the opinion of the investigator, makes the subject unsuitable for study participation.
• Prior history of solid organ or hematopoietic stem cell transplantation.
• History of any other liver disease that the investigator considers unsuitable for trial.History of autoimmune disease or diseases with potential immune activation risk.
• History or presence of hepatic decompensation at screening.
• History of primary liver cancer, or diagnosis/suspected liver cancer at screening.
• Imaging or histological evidence of significant liver fibrosis or cirrhosis within 12 months prior to screening, or a liver stiffness measurement indicative of significant fibrosis or cirrhosis at screening. Major trauma or major surgery within 12 weeks prior to screening
• History of severe allergies (e.g., to ≥2 allergens) or severe allergy to any component of the study drug, or in the opinion of the investigator, makes the subject unsuitable for participation.
• Severe infection requiring intravenous anti-infective therapy within 2 weeks prior to screening (excluding chronic HBV infection).
• History of drug abuse, or alcoholism.
• Blood donation or blood loss exceeding the specified volume within 12 weeks prior to screening, or planned blood donation during the trial period.
• Use of immunosuppressants, immunomodulators, cytotoxic drugs, or biologics within 6 months prior to screening.
• Use of any oligonucleotide drugs or interferon therapy within 12 months prior to screening.
• Vaccination within 4 weeks prior to screening, or planned vaccination during the trial period.
• Presence of tattoos, active skin diseases, or other conditions that may interfere with subcutaneous drug administration or observation of injection site reactions.
• Clinically significant abnormal electrocardiogram (ECG) at screening.
• Tested positive for HIV，HCV or active syphilis infection.
• Uncontrolled hypertension at screening.
• Clinically significant abnormal laboratory test as specified in protocol at screening.
• Currently participating in another clinical trials, or within the washout period.
• Any other condition or factor which, in the opinion of the investigator, makes the subject unsuitable for trial participation.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 10 центров

• AusperBio Investigational Site — Пекин
• AusperBio Investigational Site — Чунцин
• AusperBio Investigational Site — Xiamen
• AusperBio Investigational Site — Гуанчжоу
• AusperBio Investigational Site — Nanning
• AusperBio Investigational Site — Чжэнчжоу
• AusperBio Investigational Site — Changzhou
• AusperBio Investigational Site — Jilin City
• … и ещё 2 центра

Идентификаторы

NCT: NCT07630727 · AB-17-8003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗