A Randomized, Open-label, Multi-center Clinical Trial to Evaluate Addition of Peginterferon Alfa-2a to CHB Patients Treated With NAs and Achieved HBV DNA<15 IU/ml、HBeAg<100 PEIU/ml、HBsAg Positive and HBsAg<1500 IU/ml.
试验速览
- 阶段
- 4 期
- 入组人数
- 114
- 试验地点
- 5
- 主要终点
- The rate of HBsAg loss
研究概览
简要总结
This study evaluates whether addition of Peginterferon alfa-2a to CHB Patients Treated with nucleoside analogues (NAs) can enhance the rate of HBsAg clearance at end of treatment. This study is a Randomized, open-label, multi-center study.
The CHB patients with NAs treatment and have achieved HBV DNA <15 IU/ml、HBeAg <100 PEIU/ml、HBsAg positive and HBsAg<1500 IU/ml will be randomized into 2 groups:
Group 1 (Combination group): Maintain NAs treatment while add 48-week standard treatment by Peginterferon alfa 2a 180µg/week Group 2 (Mono NA group) : Maintain NAs treatment for 49 weeks. Note: NAs including: LAM, ADV, ETV, or TDF.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients >18 and ≤65 years of age;
- •Diagnosed chronic hepatitis B (HBsAg(+) for over 6 months before nucleos(t)ide analogues treatment)
- •Patients had achieved HBV DNA<15 IU/ml、HBeAg<100 PEIU/ml、HBsAg positive and HBsAg<1500 IU/ml on treatment of Nucleoside (acid) Analogues (including LAM, ADV, ETV, and TDF )
排除标准
- •Decompensated liver disease: including ascites, hepatic encephalopathy, esophagogastric-varicosis and fissure bleeding and other decompensated complication;
- •Hypersensitive to interferon(IFN) or its active substance, and ineligible to IFN;
- •A history of immunoregulation drug therapy within 1 year before entry including IFN and so on;
- •Coinfection with HAV、HCV、HDV、HEV 、HIV or with Other chronic liver diseases such as Alcoholic Liver Disease,Inherited Metabolic Liver Disease,Drug induced Liver Disease and nonalcoholic fatty liver, autoimmune disease including autoimmune hepatitis and Psoriasis and so on;
- •Hepatocellular carcinoma(HCC) or alpha feto protein(AFP) levels more than 100ng/ml and Hepatic malignant potential of Imaging examination or AFP levels more than 100 ng/ml for 3 months;
- •A neutrophil count of less than 1500 per cubic millimeter or a platelet count of less than 90,000 per cubic millimeter;
- •A serum creatinine level that was more than 1.5 times the upper limit of the normal range;
- •With other malignant tumors(exclude the cured ones);
- •Severe organ dysfunction;
- •With severe psychiatric condition or nervous disease such as epilepsy, depression, mania, epilepsy, schizophrenia and so on;
- •Uncontrolled diabetes, hypertension or thyroid disease;
- •Pregnant women and lactating women or patients with pregnancy plans and not willing to use contraception during the study period;
- •Participate in other clinical studies at the same time;
- •Patients unsuitable for the research;
研究组 & 干预措施
Combination group
Maintain NAs treatment while add 48-week standard treatment by Peginterferon alfa 2a 180µg/week
干预措施: Peginterferon alfa-2a (Drug)
结局指标
主要结局
The rate of HBsAg loss
时间窗: 48 weeks
To determine the response rate will be evaluated by HBsAg loss defined as HBsAg level lower than 0.05 IU/ml after 48 week treatment, compared with control group.
次要结局
- Decline of HBeAg quantification(12 weeks, 24 weeks, 48 weeks of treatment)
- Sustained virological response rate(12 weeks, 24 weeks, 48 weeks of treatment)
- The rate of HBeAg seroconversion(48 weeks)
- Decline of HBsAg quantification(12 weeks, 24 weeks, 48 weeks of treatment)
- The rate of HBeAg loss(48 weeks)
- The rate of HBsAg seroconversion(48 weeks)
研究者
Jiashang
M.D.
Henan Provincial People's Hospital