TPO-RA: The subjects will receive an initial dose of TPO-RA once daily. Platelet counts were collected weekly until week 6 of the study. Dosage was adjusted to maintain platelet levels between 50×10\^9/L and 150×10\^9/L according to platelet count. TPO-RA was administered once a day for 4 weeks. If the platelet count dose not reach 30×10\^9/L, the treatment was stopped. If the platelet count is more than 400×10\^9/L after taking TPO-RA once a day for 2 consecutive weeks, the treatment will be stopped.
Study 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-line in the previous treatment .
Eligibility
Sex
ALL
Min age
14 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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.
Primary outcome measure(s)
Treatment response — From the start of study treatment (Day 1) up to the end of week 6 Percentage of participants whose platelet count achieving response (R) within 6weeks.
Trial sites (1)
Facility
City
Region
Status
Institute of Hematology & Blood Diseases Hospital
Tianjin
Tianjin Municipality
Recruiting
More Institute of Hematology & Blood Diseases Hospital, China trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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