NCT07183293尚未招募不适用
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
Xiamen Humanity Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年10月1日最近更新:
干预措施
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
- 2
- 主要终点
- Change in liver histological score from baseline
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Group 1
Experimental
干预措施: Peginterferon alfa-2b combined with NAs (Drug)
Group 2
Experimental
干预措施: NAs (Drug)
结局指标
主要结局
Change in liver histological score from baseline
时间窗: 24 weeks after the end of treatment
次要结局
- Incidence of hepatocellular carcinoma (HCC)(Week 48)
- Incidence of hepatic decompensation events(Week 48)
- Change in liver stiffness measurement (LSM) from baseline(Week 48,24 weeks after the end of treatment)
- Change in AST-to-Platelet Ratio Index (APRI) from baseline(Week 48,24 weeks after the end of treatment)
- Change in Fibrosis-4 Index (FIB-4) from baseline(Week 48,24 weeks after the end of treatment)
- HBsAg loss rate(Week 48,24 weeks after the end of treatment)
- Seroconversion rate(Week 48,24 weeks after the end of treatment)
- HBeAg loss rate(Week 48,24 weeks after the end of treatment)
- HBV DNA undetectability rate(Week 48,24 weeks after the end of treatment)
- HBV RNA undetectability rate(Week 48,24 weeks after the end of treatment)
- HBV RNA decline rate(Week 48,24 weeks after the end of treatment)
研究者
Wenqi Huang
Chief physician
Xiamen Humanity Hospital
研究点 (2)
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