NCT05694325

Biologic Characterization of Patients With ITP

Biologic Characterization of Patients With Immune Thrombocytopenia (ITP)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a no-profit, multicenter, biological, non-pharmacologic study aimed to characterize from a biological point of view previously untreated primary ITP patients. To this end, peripheral blood, fecal and bone marrow samples will be collected at baseline and at 30 days and 180 days after treatment initiation - for each line of therapy - and the results of the biological analysis performed at each time point will then be compared.

Detailed description

This is a no-profit, multicenter, biological, non-pharmacologic study aimed to characterize from a biological point of view ITP patients. Patients with previously untreated primary ITP who need first-line therapy will be included in the study. To this end, peripheral blood, fecal and bone marrow samples will be collected at baseline and at 30 days and 180 days after treatment initiation. The same assessments will be repeated in case of any potential new line of therapy. The results of the biological analysis performed at each time point will then be compared, in order to seek changes related to the natural history of the disease, the therapy administered and the response achieved.

Conditions

• Immune Thrombocytopenia

Interventions

Type	Name	Description
OTHER	peripheral blood and bone marrow withdrawal	samples evaluation

Timeline

• Start date: 2023-11-27
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2023-01-23
• Last updated: 2024-05-21

Locations

5 sites across 1 country: Italy