TPO-RA in Primary Immune Thrombocytopenia (ITP) in Patients Older Than 14 Years
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14+
SponsorInstitute of Hematology & Blood Diseases Hospital, China
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
TPO-RA
DrugThe 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Treatment groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Treatment response
Percentage of participants whose platelet count achieving response (R) within 6weeks.
Time frame
From the start of study treatment (Day 1) up to the end of week 6Secondary outcomes
1
Treatment response
Percentage of participants achieving a platelet count \>=50×10\^9/L at week 1,2,3,4,5and 6 of treatment.
Time frame
From the start of study treatment (Day 1) up to the end of week 1,2, 3, 4, 5 and 6.2
Treatment response
Percentage of participants achieving a platelet count \>=100×10\^9/L at week 1,2,3,4,5and 6 of treatment.
Time frame
From the start of study treatment (Day 1) up to the end of week 1,2, 3, 4, 5 and 6.3
Duration of response
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).
Time frame
From the start of study treatment (Day 1) up to the end of week 64
Concomitant medication
The percentage of patients with reduced concomitant medication, reduced bleeding and remedial treatment.
Time frame
From the start of study treatment (Day 1) up to the end of week 6Sponsors and contacts
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Source ClinicalTrials.gov