Phase
Condition
White Cell Disorders
Thrombosis
Dysfunctional Uterine Bleeding
Treatment
TPO-RA
Clinical Study ID
Ages > 14 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Men and women greater than or equal to 14 years of age.
Participants diagnosed with primary immune thrombocytopenia with two platelet countsof < 30x10^9/L or with bleeding at least 7 days apart,do not have evidence of othercauses of thrombocytopenia (e.g.,pseudothrombocytopenia, myeloid fibrosis).
Previous treatment with poor response to first-line therapy and any of the maximum 4-week doses of eltrombopag, herombopag, avatrombopag, or 300U/kg/ day × 14-dayrhTPO with no response to treatment (platelet count < 30×109/L after treatment, orplatelet count increase less than twice the baseline value, or with bleeding)
Participants willing and able to comply with the requirements of the study protocol,and sign the informed consent.
Exclusion
Exclusion Criteria:
Patients diagnosed with secondary immune thrombocytopenia.
A history of arteriovenous thrombosis, disseminated intravascular coagulation,myocardial infarction, cerebral obstruction, thrombotic microangiopaemia, autoimmunediseases, malignant tumors, liver cirrhosis and other diseases that were noteligible for inclusion.
Liver disease with one of the following indicators: a. total bilirubin ≥ 2 times ofthe upper limit of normal; b. alanine aminotransferase (ALT) and aspartateaminotransferase (AST) ≥ 2 times the upper limit of normal value; Patients withrenal disease (serum creatinine ≥ 1.5 times the upper limit of normal);
Subjects with known allergies to eltrombopag, herombopag, rh-TPO, avatrombopag, orany of excipients;
Have used rituximab in the past 3 months;
Splenectomy in recent 3 months;
Those who are not considered suitable for this study by the researcher;
Women who are pregnant or who intend to become pregnant in the near future areexcluded.
Study Design
Study Description
Connect with a study center
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin 300020
ChinaActive - Recruiting
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