Clinical Study of Antiviral Therapy Combined With Novel Immunotherapy for Chronic Hepatitis B in Adults
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- HBsAg clearance at 48 weeks.
研究概览
简要总结
Establish a study cohort of adult chronic hepatitis B antiviral treatment based on the principle of responseguidedtreatment (RGT) corresponding to the child cohort, analyze the clinical cure factors of IC and IT stage adults chronic hepatitis B, and optimize the antiviral treatment plan. To determine the safety and efficacy of PD-1 antibody combined with Peg-FNa-2b in the treatment of adult NAs patients with CHB advantage.
详细描述
This research group established an adult randomized controlled study cohort corresponding to the children cohort: 1 immunetolerance (IT) and 1 immuneclearance (IC) antiviral treatment cohort, respectively according to 1: 1 Randomly divided into two intervention groups: nucleoside (acid) analogues (NAs) and NAs combined with pegylated interferon α-2b (PegIFNα-2b). 1 NAs treatment-advantaged population antiviral combined with novel immunotherapy cohort: PD-1 antibody, PegIFNα-2b and combination group were randomly enrolled 1:1:1, and the response guidance treatment plan was adjusted according to the response of patients during treatment, the HBsAg clearance rate at 24 weeks and 48 weeks of different optimal treatment groups was evaluated, the clinical curative characteristics and differences between children and adults were compared, and the key factors affecting clinical cure were screened. To determine the safety and efficacy of PD-1 antibody combined with Peg-FNa-2b in the treatment of adult NAs patients with CHB advantage.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years old；
- •Meet the 2022 Chronic Hepatitis B Guidelines definition of chronic HBV infection: HBsAg and/or HBVDNA positive >6 months;；
- •Immune clearance period: HBeAg positive, HBVDNA positive, ALT>40U/L;
- •Newly treated patients;
- •Willing to sign informed consent
排除标准
- •Patients with HAV, HCV, HEV infection and autoimmune liver disease; Pregnant and lactating women and patients who plan to give birth in the near future;
- •Patients with cirrhosis or liver cancer indicated by imaging or liver hardness testing;
- •A history of serious heart disease, including unstable or uncontrolled heart disease within the last 6 months;
- •Have a mental illness or history of mental illness;
- •Have uncontrolled seizures;
- •Alcoholics or drug users who have not abstained;
- •Have uncontrolled diabetes, hypertension, thyroid disease, retinopathy, autoimmune disease, etc.
研究组 & 干预措施
Treatment Group
NAs combined with PegIFNa-2b therapy
干预措施: Peg interferon alfa-2b (Drug)
结局指标
主要结局
HBsAg clearance at 48 weeks.
时间窗: 48weeks
HBsAg clearance in enrolled patients at week 48.（The detection of serum HBV markers is carried out using a HBsAg quantitative Elecsys （Roche Diagnostics GmbH, German）, with a HBsAg quantitative detection limit of 0.05IU/mL.）
次要结局
- The degree of serum HBsAg and HBeAg reduction from baseline at week 24, 48, 72 and 24 weeks after drug withdrawal(24 weeks,48 weeks,72 weeks)
- Evaluation of drug safety during treatment(36 months)
- The proportion of serum HBVDNA lower than the lower limit of detection at week 24, 48, 72 and 24 weeks after drug withdrawal(24 weeks,48 weeks,72 weeks)
- Serum HBsAg clearance or conversion rates at week 24, week 72, and week 24 after drug withdrawal(24 weeks,72 weeks)
- HBeAg conversion rate at week 24, 48, 72 and 24 weeks after drug withdrawal(24 weeks,48 weeks,72 weeks)
研究者
Yao Xie
Head of Department
Beijing Ditan Hospital