Multi-center Study of IFN Combined With Nucleosides Analog Antiviral Therapy in Pediatric Patients With HBeAg Positive Chronic Hepatitis B (CHB) Aged 1-16 Years
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The rates of HBsAg serological disappearance / conversion in CHB patients at 144 weeks
研究概览
简要总结
The purpose of this study is to provide theoretical and real world evidence for the optimization of antiviral treatment by IFN combined with Nucleosides analog in HBeAg positive chronic hepatitis B patients aged 1-16 years，so that the functional cure could be achieved in the greatest extent in pediatric patients
详细描述
This research is a national multicenter, randomized, prospective study. The planned sample size is 200 subjects in 1-16 years pediatric patients with HBeAg positive Chronic Hepatitis B (CHB). These subjects will be randomized (1:1) to group A(treated with NAs + IFN for 96 weeks) and group B(treated with NAs for 48 weeks, then NAs combined with IFN for 96 weeks).Meanwhile, 1-6 years and 7-16 years patients should be distributed by 1:1 ratio by random method in both groups. Regularly Blood cell count, biochemical test, hepatitis B viral markers test, and lymphocyte subsets test were exerted. To compare the curative effect of group A and group B, The primary monitoring indicator is HBsAg clearance rate, and the secondary monitoring indicator is hepatitis B virus (HBV) DNA clearance，HBeAg seroconversion in these patients,. So that we can make the optimal antiviral treatment strategy for 1-16-year-old children with CHB，and try to find out the possible influencing factors of function cure
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
- 1 Year 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 1 to 16 years old.
- •Chronic Hepatitis B (CHB) patients or HBsAg positive > 6 months patients who are line with the diagnostic criteria for chronic hepatitis B infection.
- •ALT:40～400 U/L.
- •HBeAg positive.
- •HBV DNA>2×104IU/L.
- •Liver histology: G<
- •Agree to sign the Informed Consent Form (Children aged 1-6 years may be signed by the guardian; children between the ages of 7 and 11 are in principle signed by the child and the guardian; those over the age of 12 must be signed by the child and the guardian)
排除标准
- •white blood cell (WBC)< 3.5×109/L，PLT< 80×1012/L，Pt A<60%，total bilirubin (TBIL)>34umol/L，ALB<35g/L，Cr>133umol/L.
- •Combined with HAV、HCV、HDV、HEV or HIV-infected persons.
- •Patients combined with other causes of liver disease：alcoholic or non-alcoholic liver disease，thyroid disease，autoimmune liver disease，genetic metabolic liver disease，bile duct diseases，or Parasitic infection of hepatobiliary tract.
- •Patients with decompensated cirrhosis，including ascites.
- •Received the following medications（Immunosuppressant and Systemic cytotoxic drugs）in six months.
- •Patients who are allergy to IFNs and NAs;
- •Patients with other severe or active psychosomatic diseases （kidney, heart, lungs, vascular, neurological, digestive including history of pancreatitis, metabolic diseases including diabetes, thyroid and Adrenal disease, adrenal disease or tumor), Researchers believe which affect the treatment, evaluation or compliance of patients with the study plan.
- •Patients who unable to comply with the study arrangement judged by researcher.
研究组 & 干预措施
NAs+(IFN-α+ NAs )
NAs/48w+(IFN-α+ NAs)/96w
干预措施: NAs+IFN-α (Drug)
NAs+IFN-α
NAs+IFN-α/ 96w
干预措施: NAs+IFN-α (Drug)
结局指标
主要结局
The rates of HBsAg serological disappearance / conversion in CHB patients at 144 weeks
时间窗: 144 weeks
The rates of HBsAg serological disappearance / conversion in CHB patients at 144 weeks
The rates of HBsAg serological disappearance / conversion in CHB patients at 48 weeks
时间窗: 48 weeks
The rates of HBsAg serological disappearance / conversion in CHB patients at 48 weeks
The rates of HBsAg serological disappearance / conversion in CHB patients at 96 weeks
时间窗: 96 weeks
The rates of HBsAg serological disappearance / conversion in CHB patients at 96 weeks
The rates of HBsAg serological disappearance / conversion in CHB patients at 168 weeks
时间窗: 168 weeks
The rates of HBsAg serological disappearance / conversion in CHB patients at 168 weeks
次要结局
- The rate of HBeAg clearance / seroconversion(168 weeks)
- HBV DNA negative conversion rate(168 weeks)
- ALT(Alanine aminotransferase) recovery rate(168 weeks)