TPO-RA in Primary Immune Thrombocytopenia (ITP) in Patients Older Than 14 Years

Institute of Hematology & Blood Diseases Hospital, China

Status

Enrolling

Conditions

Primary Immune Thrombocytopenic Purpura

Treatments

Drug: TPO-RA

Study type

Interventional

Funder types

Other

Identifiers

NCT04890041

IIT2020033

Details and patient eligibility

About

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 .

Full 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.

100 eligible subjects will be enroll ed in this study.The dose will be adjusted according to the subject platelet count during the period from week 1 to week 6.

Enrollment

100 estimated patients

Sex

All

Ages

14+ years old

Volunteers

No Healthy Volunteers

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.