A Clinical Controlled Study to Optimize the Therapeutic Pathway of Peginterferon Alfa-2b Treatment in Patients With Chronic Hepatitis B Based on IFNA2p.Ala120Thr /ISGs Gene Spectrum.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- HBsAg clearance rate
研究概览
简要总结
The study is to guide clinical cure of peginterferon alfa-2a treatment in patients with chronic hepatitis B based on the detection of interferon gene mutation (IFNA2p.Ala120Thr) and interferon-stimulated genes (ISGs) detection gene spectrum.
详细描述
It is estimated that more than 400 million people are infected with hepatitis B virus (HBV) globally.How to make more patients with chronic hepatitis B get clinical treatment through the existing anti-viral treatment is an urgent problem to be solved.This study is a random, multi-center and open experiment,the collaborators includes the second people's hospital of zhongshan city, the eighth people's hospital of guangzhou city, and the first people's hospital of foshan city.
Patients with chronic hepatitis B who were treated with NAs for over 1 year,HBsAg quantification≤1500 IU/mL, HBeAg negative and serum HBV DNA quantification <100 IU/mL were enrolled in this study. In our study, the enrolled patient's IFNA2p.Ala120Thr without variation and ISGs>0.05 were divided into two groups. After informed consent , patients were grouped according to their treatment intentions,in one group, patients continued NAs for another 48 weeks. In another group , patients were treated with peg-interferon-2a and NAs for 48 weeks.Patient's BMI, genotype, family history, smoking history, drinking history, other medical history, suspected transmission channels, types and time of use were recorded in this study.Moreover, Patients were assessed every 12 weeks,included liver and kidney function, blood routine, HBV cccDNA, HBeAg quantification, HBsAg quantification, pgRNA and so on.In addition,liver imaging examination and liver hardness test were assessed every six months.
In this study, we will analyze whether clinical cure rates differed between patients with chronic hepatitis B treated with peginterferon alfa-2a and NAs;Bisedes,the baseline interferon variant site variants and changes in interferon-stimulated gene profile expression were analyzed to determine whether they could be used as molecular markers to predict clinical cure with interferon.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Active Comparator:nucleotide analogues(NAs) patients continue to use NAs
Experimental: peg-interferon alfa-2a patients switch to sequential peg-interferon α-2a
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
- •Age between 18 and 60 years old;
- •HBsAg positive, HBsAg quantification≤1500 IU/mL;
- •Serum HBV DNA quantification <100 IU/mL;
- •HBeAg negative.
排除标准
- •Treated with interferon in the past six months;
- •Liver cirrhosis or HCC and other associated tumors;
- •Women during pregnancy or lactation;
- •With liver disease caused by other causes;
- •Combination infection of HIV or other immunodeficiency diseases;
- •With diabetes, autoimmune diseases and other organ dysfunction or failure;
- •Combination of other serious complications (infection, hepatic encephalopathy,gastrointestinal bleeding, hepatorenal syndrome, etc.);
- •Others who cannot be treated with interferon;
- •Anyone cannot return to the hospital for follow-up and follow-up visits regularly as planned
研究组 & 干预措施
Active Comparator:NAs group
Active Comparator:nucleotide analogues(NAs)
patients continue to use NAs
干预措施: Nucleotide Analog (Drug)
Experimental:PEG-IFN group
Experimental: peg-interferon alfa-2a
patients use peg-interferon α-2a and nucleotide analogues(NAs)
干预措施: Nucleotide Analog (Drug)
Experimental:PEG-IFN group
Experimental: peg-interferon alfa-2a
patients use peg-interferon α-2a and nucleotide analogues(NAs)
干预措施: Interferon Alfa-2A (Drug)
结局指标
主要结局
HBsAg clearance rate
时间窗: 48 weeks
Whether the HBsAg clearance rate of patients who received interferon treatment was higher than those treated with nucleoside drugs.
次要结局
- HBV cccDNA and pgRNA quantification dynamic change(48 weeks)
研究者
Chan Xie
Professor of department of infectious disease Third Affiliated Hospital,Sun Yat-Sen University
Sun Yat-sen University