Status:
RECRUITING
TPO-RA in Primary Immune Thrombocytopenia (ITP) in Patients Older Than 14 Years
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Primary Immune Thrombocytopenic Purpura
Eligibility:
All Genders
14+ years
Phase:
NA
Brief Summary
This multi-center study aims to study the efficacy of TPO-RAs' transformation in Chinese ITP patients older than 14 years. This study will be conducted in ITP patients who had not responded to first-l...
Detailed Description
The primary objective of this study was to evaluate the efficacy of TPO-RAs' transformation in Chinese ITP patients older than 14 years who had not responded to first-line in the previous treatment. ...
Eligibility Criteria
Inclusion
- Men and women greater than or equal to 14 years of age.
- Participants diagnosed with primary immune thrombocytopenia with two platelet counts of \< 30x10\^9/L or with bleeding at least 7 days apart，do not have evidence of other causes 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-day rhTPO with no response to treatment (platelet count \< 30×109/L after treatment, or platelet 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
- Patients diagnosed with secondary immune thrombocytopenia.
- A history of arteriovenous thrombosis, disseminated intravascular coagulation, myocardial infarction, cerebral obstruction, thrombotic microangiopaemia, autoimmune diseases, malignant tumors, liver cirrhosis and other diseases that were not eligible for inclusion.
- Liver disease with one of the following indicators: a. total bilirubin ≥ 2 times of the upper limit of normal; b. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 2 times the upper limit of normal value; Patients with renal disease (serum creatinine ≥ 1.5 times the upper limit of normal);
- Subjects with known allergies to eltrombopag, herombopag, rh-TPO, avatrombopag, or any 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 are excluded.
Key Trial Info
Start Date :
May 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04890041
Start Date
May 30 2021
End Date
December 31 2025
Last Update
February 24 2025
Active Locations (1)
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1
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China, 300020