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Clinical Trials in Italy / NCT05694325
Recruiting Not applicable

Biologic Characterization of Patients With ITP

NCT05694325 · tracked via the Priya Life Science Italy tracker
Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Phase
Not applicable
Started
2023-11-27
Last updated
2024-05-21

Condition(s) studied

Immune Thrombocytopenia

Investigational drug(s) / intervention(s)

peripheral blood and bone marrow withdrawal

peripheral blood and bone marrow withdrawal: samples evaluation

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Patients with primary ITP, in need for first line treatment according to 2019 ITP consensus2. 2. Previously untreated patients. Patients who have already started first-line therapy because of life-threatening bleeding are admitted to the study if samples are collected within 24 hours of starting treatment. In such cases, as first-line treatment steroids and platelet transfusions would be preferable over high-dose IVIg. Treatment received before the collection of samples will be carefully documented. 3. Age ≥ 18 years 4. Signed written informed consent according to ICH/EU/GCP and national local laws. Exclusion Criteria: 1\. Secondary ITP. Patients with ANA positivity without a diagnosis of SLE are admitted to the study. As far as patients with ITP and antiphospholipid antibodies positivity, those with triple positivity (anti-beta2glicoprotein antibodies, anti-cardiolipin antibodies, lupus anticoagulans positivity) are excluded.

Primary outcome measure(s)

  • B-cell mediated disease incidence — at baseline
    evaluation of percentage of patients with a predominant B-cell mediated disease

Trial sites (5)

FacilityCityRegionStatus
UOC ematologia AOU di Bologna Bologna Italy Recruiting
Ematologia e centro trapianti ASL Piacenza Piacenza Italy Recruiting
Ematologia Policlinico Universitario A.Gemelli Roma Italy Recruiting
Sc Ematologia Ospedale S.G. Battista Molinette - Università Degli Studi Di Torino Torino Italy Recruiting
SC Ematologia ASUGI Trieste Italy Recruiting

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Other trials for the same condition

Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment Recruiting
Prospective Evaluation of Diagnosis and Treatment of Patients With Autoimmune Cytopenias Including Autoimmune Hemolytic Anemia, Immune Thrombocytopenia, and Chronic Idiopathic/Autoimmune Neutropenia Recruiting
Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05694325 on ClinicalTrials.gov ↗ ← All trials in Italy