A Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB)

Официальное название

An Open-Label, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Low-HBsAg Chronic Hepatitis B

Обзор

This is an open-label, multicenter, Phase 2 study designed to evaluate the efficacy and safety of AHB-137 injection in participants with chronic hepatitis B (CHB) with low hepatitis B surface antigen (HBsAg) levels.

Вмешательства

• Препарат AHB-137
  AHB-137 will be injected
• Препарат NA therapy
  NA will be usede.

Первичные конечные точки

• 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. [Срок оценки: At the 24th week after all treatment for CHB was discontinued]

Вторичные конечные точки (10)

• Proportion of participants with persistent HBV DNA < LLOQ . [Срок оценки: During the 24-week period after discontinuation of all CHB treatment]
• Proportion of participants with persistent HBsAg < limit of detection (LOD) and HBV DNA < lower limit of quantification (LLOQ). [Срок оценки: Up to 60 weeks]
• Detection of the concentration of HBsAg, HBsAb, HBV DNA, HBV RNA, HBcrAg, HBeAb,and HBeAg. [Срок оценки: Up to 60 weeks]
• Relapse rate and time after discontinuation of NAs therapy. [Срок оценки: Up to 60 weeks]
• Changes of the score of Health-Related Quality of Life (HBQOL) in participants compared with baseline. [Срок оценки: Up to 60 weeks]
• Changes of the score of EuroQol Five-Dimension Five-Level Scale (EQ-5D-5L) in participants compared with baseline. [Срок оценки: Up to 60 weeks]
• Number and percentage of participants with detectable anti-drug antibodies (ADA). [Срок оценки: Up to 60 weeks]
• Sequencing of the Viral DNA and/or viral RNA analysis for detection of drug resistance in the target region of AHB-137. [Срок оценки: Up to 60 weeks]
• Safety: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAE) and clinically significant examination results. [Срок оценки: Up to 60 weeks]
• Plasma concentrations of AHB-137. [Срок оценки: Up to 60 weeks]

Критерии участия

Критерии включения

• Voluntarily participate in the study and sign the informed consent form;
• 18-65 years of age (including boundary values) ;
• Body mass index met the requirements;
• Participants with CHB who are HBsAg or HBV DNA positive for at least 6 months;
• Meet the relevant requirements for prior medications;
• HBsAg and HBV DNA and liver function indicators meet the requirements;
• Effective contraception as required;

Критерии исключения

• Uncontrolled and stable clinically significant abnormalities other than a history of CHB infection;
• Associated liver disease;
• Any serious infection other than CHB infection requires intravenous anti-infective therapy;
• HCV RNA positive, HIV antibody positive, syphilis positive;
• Abnormal laboratory results;
• Diseases associated with vascular inflammatory conditions;
• QT interval corrected heart rate (Fridericia method) abnormal;
• History of malignancy or ongoing assessment of possible malignancy;
• History of allergies, or allergic constitution;
• Participants with recent major trauma or major surgery, or planning surgery;
• Those who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study;
• Prior/current use of prohibited medications;
• Inappropriate for participation in this trial as judged by the investigator.

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 · 12 центров

• AusperBio Investigational Site — Пекин
• AusperBio Investigational Site — Jilin City
• AusperBio Investigational Site — Чунцин
• AusperBio Investigational Site — Чунцин
• AusperBio Investigational Site — Xiamen
• AusperBio Investigational Site — Гуанчжоу
• AusperBio Investigational Site — Шэньчжэнь
• AusperBio Investigational Site — Nanning
• … и ещё 4 центра

Идентификаторы

NCT: NCT07137910 · AB-10-8009

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗