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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
117
Thrombopoietin receptor agonist
Percentage of subjects with new myelofibrosis,new cataract, or existing cataract progression during the extended study.
Time frame: from baseline to 28 days after the last dose
All AESIs,whether or not associated with study drugs.
Time frame: from baseline to 28 days after the last dose
All SAEs,whether or not associated with study drugs.
Time frame: from baseline to 28 days after the last dose
All AEs that result in discontinuation of medication.
Time frame: from baseline to 28 days after the last dose
All AEs that lead to permanent withdrawal.
Time frame: from baseline to 28 days after the last dose
Blood Biochemistry-ALT.
Time frame: 6 months
Blood Biochemistry-AST.
Time frame: 6 months
Blood Biochemistry-GGT.
Time frame: 6 months
Blood Biochemistry-ALP.
Time frame: 6 months
Blood Biochemistry-TBIL.
Time frame: 6 months
Blood Biochemistry-DBIL.
Time frame: 6 months
Blood Biochemistry-creatinine.
Time frame: 6 months
Platelet count at each visiting point.
Time frame: 6 months
The incidence and severity of bleeding symptoms.
According to the 2021 version go pediatric ITP bleeding Score Scale.
Time frame: 6 months
Percentage of subjects receiving emergency treatment for aggravated ITP.
Time frame: 6 months
Percentage of subjects with recurrent ITP.
Time frame: 6 months
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