Actively Recruiting
Biologic Characterization of Patients With ITP
Led by Gruppo Italiano Malattie EMatologiche dell'Adulto · Updated on 2024-05-21
200
Participants Needed
5
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Biologic Characterization of Patients With ITP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with primary ITP who need first-line treatment according to 2019 ITP consensus
- Patients who have not received prior treatment; those who started first-line therapy due to life-threatening bleeding can join if samples are collected within 24 hours of treatment start
- Age 18 years or older
- Signed written informed consent according to ICH/EU/GCP and local laws
You will not qualify if you...
- Patients with secondary ITP
- Patients diagnosed with systemic lupus erythematosus (SLE)
- Patients with triple positivity for antiphospholipid antibodies (anti-beta2 glycoprotein, anti-cardiolipin, lupus anticoagulant)
AI-Screening
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Trial Site Locations
Total: 5 locations
1
UOC ematologia AOU di Bologna
Bologna, Italy
Actively Recruiting
2
Ematologia e centro trapianti ASL Piacenza
Piacenza, Italy
Actively Recruiting
3
Ematologia Policlinico Universitario A.Gemelli
Roma, Italy
Actively Recruiting
4
Sc Ematologia Ospedale S.G. Battista Molinette - Università Degli Studi Di Torino
Torino, Italy
Actively Recruiting
5
SC Ematologia ASUGI
Trieste, Italy
Actively Recruiting
Research Team
P
Paola Fazi
CONTACT
E
Enrico Crea
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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