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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in intrahepatic cccDNA and peripheral blood pgRNA levels
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Peginterferon α-2b based group
干预措施: Peginterferon α-2b based injection (Drug)
结局指标
主要结局
Changes in intrahepatic cccDNA and peripheral blood pgRNA levels
时间窗: baseline to week48
Clearance rate of intrahepatic cccDNA
时间窗: week48
次要结局
- Correlation between changes in intrahepatic cccDNA levels and interferon consolidation therapy(baseline to week48)
- Correlation between intrahepatic cccDNA clearance and interferon consolidation therapy(week48)
- intrahepatic HBsAg clearance rate(baseline、week48)
- Recurrence rate(baseline to week48)
- Correlation between changes in peripheral blood pgRNA levels and interferon consolidation therapy(baseline to week48)
- Changes in intrahepatic HBsAg levels(baseline to week48)
- Adverse Event#AE#(baseline to week48)
- Changes in intrahepatic cccDNA levels(baseline to week48)
- Histopathological scores in hepatic inflammation and fibrosis(baseline、week48)
研究者
Liang Huiqing
Chief physician
Xiamen Hospital of Traditional Chinese Medicine