TPO-RA in Primary Immune Thrombocytopenia (ITP) in Patients Older Than 14 Years
Efficacy of TPO-RA in the Management of Primary Immune Thrombocytopenia (ITP) in Patients Older Than 14 Years With Poor First-line Response: a Multi-center, Prospective, One-arm Study
Institute of Hematology & Blood Diseases Hospital, China
100 participants
May 30, 2021
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria8
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04890041