Biologic Characterization of Patients With Immune Thrombocytopenia (ITP)

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
UOC ematologia AOU di Bologna
RECRUITING
Bologna
Ematologia e centro trapianti ASL Piacenza
RECRUITING
Piacenza
Ematologia Policlinico Universitario A.Gemelli
RECRUITING
Roma
Sc Ematologia Ospedale S.G. Battista Molinette - Università Degli Studi Di Torino
RECRUITING
Torino
SC Ematologia ASUGI
RECRUITING
Trieste
Contact Information
Primary
Paola Fazi
p.fazi@gimema.it
0670390528
Backup
Enrico Crea
e.crea@gimema.it
0670390514
Time Frame
Start Date: 2023-11-27
Estimated Completion Date: 2026-11
Participants
Target number of participants: 200
Treatments
Other: Biological evaluation
characterization of biological features of enrolled ITP patients
Sponsors
Leads: Gruppo Italiano Malattie EMatologiche dell'Adulto

This content was sourced from clinicaltrials.gov

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