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Набор скоро начнётся NCT07183293

A Study on Peginterferon Alfa-2b Combined With NAs in Compensated HBV Cirrhosis

Без фазы С лечением HBV-related Liver Cirrhosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Peginterferon alfa-2b combined with NAs, NAs.
Кому может быть актуально
Состояния в реестре: HBV-related Liver Cirrhosis. Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

A Multicenter, Randomized, Prospective Study on the Efficacy and Safety of Peginterferon Alfa-2b Combined With Nucleos(t)Ide Analogues in Patients With Compensated HBV-Related Liver Cirrhosis

Обзор

This study is a multicenter, randomized, prospective trial designed to evaluate the efficacy and safety of pegylated interferon α-2b (Peg-IFN-α2b) combined with nucleos(t)ide analogues (NAs) versus NAs monotherapy in patients with compensated hepatitis B cirrhosis. A total of 30 patients with compensated HBV-related cirrhosis will be enrolled and randomized in a 2:1 ratio to either Experimental Group 1 (n=20) or Experimental Group 2 (n=10). The treatment regimens consist of Peg-IFN-α2b combined with NAs (ETV/TAF/TMF/TDF) or NAs (ETV/TAF/TMF/TDF) monotherapy.

Вмешательства

  • Препарат Peginterferon alfa-2b combined with NAs
    Subcutaneous injection therapy,Treatment will continue for 48 weeks, with follow-up assessments conducted every 12 weeks. The dosage will be adjusted based on the patient's disease status.
  • Препарат NAs
    Treatment will continue for 48 weeks, with follow-up assessments conducted every 12 weeks. The dosage will be adjusted based on the patient's disease status.

Первичные конечные точки

  • Change in liver histological score from baseline [Срок оценки: 24 weeks after the end of treatment]
Вторичные конечные точки (11)
  • Incidence of hepatocellular carcinoma (HCC) [Срок оценки: Week 48]
  • Incidence of hepatic decompensation events [Срок оценки: Week 48]
  • Change in liver stiffness measurement (LSM) from baseline [Срок оценки: Week 48,24 weeks after the end of treatment]
  • Change in AST-to-Platelet Ratio Index (APRI) from baseline [Срок оценки: Week 48,24 weeks after the end of treatment]
  • Change in Fibrosis-4 Index (FIB-4) from baseline [Срок оценки: Week 48,24 weeks after the end of treatment]
  • HBsAg loss rate [Срок оценки: Week 48,24 weeks after the end of treatment]
  • Seroconversion rate [Срок оценки: Week 48,24 weeks after the end of treatment]
  • HBeAg loss rate [Срок оценки: Week 48,24 weeks after the end of treatment]
  • HBV DNA undetectability rate [Срок оценки: Week 48,24 weeks after the end of treatment]
  • HBV RNA undetectability rate [Срок оценки: Week 48,24 weeks after the end of treatment]
  • HBV RNA decline rate [Срок оценки: Week 48,24 weeks after the end of treatment]

Критерии участия

Критерии включения

  • Clinical diagnosis of compensated HBV-related liver cirrhosis (Child-Pugh class A or B);
  • The subject is able to understand and comply with the content, requirements, and restrictions of the protocol, is willing and able to complete the study per protocol requirements, fully understands the potential adverse reactions, and voluntarily provides written informed consent prior to study initiation;
  • Aged 18 to 60 years (inclusive), any gender;
  • Female subjects of childbearing potential must have a negative pregnancy test at screening;
  • Subjects (including their partners) must voluntarily use effective non-drug contraception from prior to dosing until six months after discontinuation of the study drug and have no plan to donate sperm or ova; or subjects (including their partners) are of non-childbearing potential (surgically sterilized or postmenopausal).

Критерии исключения

  • Decompensated liver cirrhosis, hepatic failure, or hepatocellular carcinoma; presence of other liver diseases such as fatty liver disease, alcoholic liver disease, drug-induced liver injury, autoimmune liver disease, or Wilson's disease;
  • History of clinically significant diseases of the cardiovascular, hematological and lymphatic, respiratory, urinary, endocrine, immune, psychiatric, or nervous systems (e.g., epilepsy), ophthalmic diseases, or thyroid-related disorders;
  • Pregnancy, lactation, or intention to become pregnant during the study period;
  • Known or suspected allergy to the investigational product(s) or any of its excipients;
  • Participation in any other interventional clinical trial within 3 months prior to screening or planning to participate in another clinical trial during the study;
  • Any other condition considered by the investigator to be inappropriate for participation in the study.

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
Открытое
Основная цель
Лечение

Центры проведения

Китай · 2 центра
  • Xiamen Hospital of Traditional Chinese Medicine — Xiamen
  • Zhongshan Hospital Affiliated to Xiamen University — Xiamen

Идентификаторы

NCT: NCT07183293 · HAXM20250731

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗