Biologic Characterization of Patients With ITP
Recruiting now · Not applicable
Conditions studied: Immune Thrombocytopenia
In brief
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.
Key facts
- Study ID
- NCT05694325
- Run by
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- People needed
- 200
- Starts
- 2023-11-27
- Expected to finish
- 2026-11-01
- Last updated by the study team
- 2024-05-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with primary ITP, in need for first line treatment according to 2019 ITP consensus2.
- 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.
- Age ≥ 18 years
- Signed written informed consent according to ICH/EU/GCP and national local laws.
You may not qualify if…
- 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.
Where it is running
- UOC ematologia AOU di Bologna — Bologna, Italy (enrolling)
- Ematologia e centro trapianti ASL Piacenza — Piacenza, Italy (enrolling)
- Ematologia Policlinico Universitario A.Gemelli — Roma, Italy (enrolling)
- Sc Ematologia Ospedale S.G. Battista Molinette - Università Degli Studi Di Torino — Torino, Italy (enrolling)
- SC Ematologia ASUGI — Trieste, Italy (enrolling)
Full record on ClinicalTrials.gov
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