Primary Immune Thrombocytopenic Purpura
Conditions
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-line in the previous treatment .
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. 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.
Interventions
DRUGTPO-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.
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment response | From the start of study treatment (Day 1) up to the end of week 1,2, 3, 4, 5 and 6. | Percentage of participants achieving a platelet count \>=50×10\^9/L at week 1,2,3,4,5and 6 of treatment. |
| Duration of response | From the start of study treatment (Day 1) up to the end of week 6 | Percentage of participants whose platelet count achieving persistence response (R) within 6weeks(defined as the proportion of subjects with a platelet count of ≥30×109/L for at least 4 weeks of the 6-week treatment period without remedial therapy). |
| Concomitant medication | From the start of study treatment (Day 1) up to the end of week 6 | The percentage of patients with reduced concomitant medication, reduced bleeding and remedial treatment. |
| Adverse events | From the start of study treatment (Day 1) up to the end of week 6 | Incidence of adverse events. |
Countries
China
Contacts
Primary ContactWei Liu
Backup ContactLei Zhang
Outcome results
None listed