Effects of Peginterferon Consolidation Therapy on Hepatic cccDNA Dynamics in CHB Patients Achieving Clinical Cure.

Официальное название

An Exploratory Clinical Study Evaluating the Impact of Interferon Consolidation Therapy on Intrahepatic cccDNA Levels in Chronic Hepatitis B Patients Who Achieved Clinical Cure With Peginterferon α-2b Therapy.

Обзор

This is a single-center, prospective, exploratory clinical study. The study plans to enroll 30 chronic hepatitis B (CHB) patients which achieved HBsAg clearance based peginterferon α-2b treatment. Eligible subjects will receive either 12-24 weeks interferon consolidation therapy (180μg administered subcutaneously in the abdomen or thigh once weekly) or not according to physician's recommendation and patient's preference, with regular follow-up for HBV recurrence. Patients will be followed up every 12 weeks. The study will evaluate changes in intrahepatic covalently closed circular DNA (cccDNA) and peripheral blood HBV pregenomic RNA (pgRNA) levels after achieving HBsAg clearance.

Вмешательства

• Препарат Peginterferon α-2b based injection
  Peginterferon α-2b injection, 180 μg administered subcutaneously in the abdomen or thigh once weekly, with regular follow-up for HBV recurrence. Patients will be followed up every 12 weeks.

Первичные конечные точки

• Changes in intrahepatic cccDNA and peripheral blood pgRNA levels [Срок оценки: baseline to week48]
• Clearance rate of intrahepatic cccDNA [Срок оценки: week48]

Вторичные конечные точки (9)

• Correlation between changes in intrahepatic cccDNA levels and interferon consolidation therapy [Срок оценки: baseline to week48]
• Correlation between changes in peripheral blood pgRNA levels and interferon consolidation therapy [Срок оценки: baseline to week48]
• Correlation between intrahepatic cccDNA clearance and interferon consolidation therapy [Срок оценки: week48]
• Changes in intrahepatic cccDNA levels [Срок оценки: baseline to week48]
• Changes in intrahepatic HBsAg levels [Срок оценки: baseline to week48]
• intrahepatic HBsAg clearance rate [Срок оценки: baseline、week48]
• Histopathological scores in hepatic inflammation and fibrosis [Срок оценки: baseline、week48]
• Recurrence rate [Срок оценки: baseline to week48]
• Adverse Event#AE# [Срок оценки: baseline to week48]

Критерии участия

Критерии включения

• Voluntarily enroll in the study, able to understand and voluntarily sign the informed consent form;
• Aged 18-65 years (inclusive), no gender restriction;
• A history of HBsAg positivity for at least 6 months or other evidence suggesting chronic hepatitis B;
• First observed clinical cure after treatment with peginterferon α-2b (PegIntron®), either as monotherapy or in combination with NAs, defined as serum HBsAg negative (<0.05IU/ml), HBV DNA undetectable (HBV DNA<20IU/ml), and HBeAg negative, within a 4-week window from the first observed day of clinical cure at the time of screening;
• Agreement to undergo two liver biopsies during the study;
• Negative pregnancy test within 24 hours before the first liver biopsy (for childbearing-age females); and subjects (both male and female) should use effective contraception during the study period.

Критерии исключения

• Lactating women;
• Evidence of acute severe liver injury: such as ALT > 10 ULN, or significantly elevated ALT with significantly elevated bilirubin;
• Evidence of decompensated liver disease: such as ascites, esophageal varices rupture bleeding, sepsis, hepatic encephalopathy, hepatorenal syndrome, etc.; or history of decompensated cirrhosis;
• Evidence of hepatocellular carcinoma;
• Prothrombin time (PT) or INR > ULN;
• Participation in other interventional trial studies within 3 months before screening or other conditions deemed unsuitable for inclusion by the investigator.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Xiamen Hospital of Traditional Chinese Medicine — Xiamen

Идентификаторы

NCT: NCT06920329 · 2024K04701

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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