NCT04890041

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Immune Thrombocytopenic Purpura

Interventions

Type	Name	Description
DRUG	TPO-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.

Timeline

• Start date: 2021-05-30
• Primary completion: 2025-11-30
• Completion: 2025-12-31
• First posted: 2021-05-18
• Last updated: 2025-02-24

Locations

1 site across 1 country: China