NCT06457477招募中不适用
The Safety and Efficacy of Sequential Combination Therapy With PD-1 Antibody and Pegylated Interferon-α in NA-supressed Chronic Hepatitis B Patients
Beijing 302 Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年6月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent adverse events/serious adverse events
研究概览
简要总结
This is a prospective study to evaluate the safety and efficacy of Sintilimab (PD-1 antibody) in sequential combination with Peg-IFNα-2b in NA-supressed CHB patients who had previously received Peg-IFNα therapy.
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
- All
- 接受健康志愿者
- 否
入选标准
- •18 - 65 years old;
- •2.Chronic hepatitis B patients with clear diagnosis of hematology, etiology and clinical (for example: HBsAg positive for more than 6 months);
- •In virologically suppressed (HBV DNA below the lower detection limit) CHB patients by NAs treatment, HBsAg decreased by less than 0.5log in the last 6 months of Peg-IFNα therapy, and then discontinued Peg-IFNα at least 6 months;
- •4.Patients with HBV DNA negative, HBeAg negative, HBsAg quantification ≤ 200IU/ml at Peg-IFNα discontinuation and enrollment.
排除标准
- •2.platelet count < 90×109/L, WBC count < 3.0×109/L, neutrophil count < 1.3×109/L, ALT > ULN (40U/L), total bilirubin > 2ULN;
- •3.History of or suspicion of hepatocellular carcinoma
- •4.Patients received immunosuppressive therapy or other therapy influenced study within 12 months;
- •5.Hepatitis A, hepatitis C, hepatitis D, HIV infection or other active infections;
- •6.Alcohol or drug abuse/dependence;
- •7.Investigator judges that the participants are not suitable for this study.
研究组 & 干预措施
PD-1 antibody therapy
Experimental
干预措施: Sintilimab (Drug)
PD-1 antibody therapy
Experimental
干预措施: NAs (Drug)
PD-1 antibody therapy
Experimental
干预措施: Peg-IFNα-2b (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events/serious adverse events
时间窗: 48 weeks
Evaluate the treatment-emergent adverse events/serious adverse events
The rate of HBsAg loss (<0.05 IU/ml) at 24 weeks and 48 weeks
时间窗: 48 weeks
Evaluate the level of HBsAg (IU/ml) at 24 weeks and 48 weeks.
次要结局
- The concentration of HBcrAg (logU/mL) at baseline, 12 weeks, 24 weeks and 48 weeks(48 weeks)
- The rate of HBsAb positive (>10 IU/ml) at 24 weeks and 48 weeks.(48 weeks)
- The concentration of pgRNA (>10 IU/ml) at baseline, 12 weeks, 24 weeks and 48 weeks(48 weeks)
- The concentration of anti-HBc (IU/ml) at baseline, 12 weeks, 24 weeks and 48 weeks(48 weeks)
- The rate of HBsAg decline > 1log(IU/ml) at 24 weeks and 48 weeks(48 weeks)
- Immune response of T cell, B cell, NK cell at baseline, 12 weeks, 24 weeks and 48 weeks(48 weeks)
研究者
研究点 (1)
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