Extension Study of Herombopag in Children and Adolescents With Chronic Primary Immune Thrombocytopenia
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 117
- 主要终点
- Blood Biochemistry-AST.
研究概览
简要总结
The main purpose of this extended study is to enable subjects who are currently receiving the PartB experimental drug in the HR-TPO-ITP-III-PED clinical trial .To continue receiving the experimental drug after the completion of the clinical trial if they benefit from the treatment at the end of the clinical trial.Until the study physician determines that the subject has failed treatment or that the subject can no longer benefit from treatment or extends the study treatment for 6 months.In addition, the secondary purpose of this extended study was to observe the long-term efficacy and safety of tripodal in children and adolescents.
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have completed PartB of HR-TPO-ITP-III-PED clinical trial and have achieved platelet response.
- •Subjects who have signed the informed consent for the extended study.
- •Subjects with potential fertility（e.g. women who have menarche or men who have sperm loss) should agree to use effective contraception during their participation in the extended study and within 28 days after their last dose.
- •Subjects who have completed end-of-treatment visits in the original study.
排除标准
- •Any unstable condition or condition that may compromise the safety of the subject.
- •Patients with new myelofibrosis were examined in the original clinical trial exit group.
- •The original clinical trial cohort examined evidence of new cataract or existing cataract progression, and the study considered it unsuitable to enroll in this extension.
- •Patients with uncontrolled bleeding after standard treatment.
- •Any previous occurrence of arterial or venous thrombosis (transient ischemic attack,myocardial infarction ,deep venous thrombus, or pulmonary embolism ),or clinical symptoms and history suggest thrombus susceptibility.
- •Any other circumstances that the investigator considers likely to cause the subject to be unable to complete the study or to present a significant risk to the subject.
研究组 & 干预措施
open-label
Herombopag plus standard of care
干预措施: Herombopag (Drug)
结局指标
主要结局
Blood Biochemistry-AST.
时间窗: 6 months
Blood Biochemistry-GGT.
时间窗: 6 months
Blood Biochemistry-ALP.
时间窗: 6 months
Percentage of subjects with new myelofibrosis，new cataract, or existing cataract progression during the extended study.
时间窗: from baseline to 28 days after the last dose
All AESIs，whether or not associated with study drugs.
时间窗: from baseline to 28 days after the last dose
All SAEs，whether or not associated with study drugs.
时间窗: from baseline to 28 days after the last dose
All AEs that result in discontinuation of medication.
时间窗: from baseline to 28 days after the last dose
All AEs that lead to permanent withdrawal.
时间窗: from baseline to 28 days after the last dose
Blood Biochemistry-ALT.
时间窗: 6 months
Blood Biochemistry-TBIL.
时间窗: 6 months
Blood Biochemistry-DBIL.
时间窗: 6 months
Blood Biochemistry-creatinine.
时间窗: 6 months
次要结局
- Platelet count at each visiting point.(6 months)
- The incidence and severity of bleeding symptoms.(6 months)
- Percentage of subjects receiving emergency treatment for aggravated ITP.(6 months)
- Percentage of subjects with recurrent ITP.(6 months)