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

Not Applicable

Recruiting

• Conditions: Primary Immune Thrombocytopenic Purpura
• Interventions: Drug: TPO-RA

• Registration Number: NCT04890041
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

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.

Study Timeline

• Study First Submitted: 2021-05-12
• Study First Submitted QC: 2021-05-12
• Study First Posted: 2021-05-18
• Study Start: 2021-05-30
• Status Verified: 2024-10
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-24
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	TPO-RA	100 subjects will be enrolled with the indicated treatment dose of TPO-RA

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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 \>=100×10\^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).

Trial Locations

Locations (1)

Institute of Hematology & Blood Diseases Hospital; 🇨🇳 Tianjin, Tianjin, China