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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05694325
Other study ID # ITP1222
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 27, 2023
Est. completion date November 2026

Study information

Verified date May 2024
Source Gruppo Italiano Malattie EMatologiche dell'Adulto
Contact Paola Fazi
Phone 0670390528
Email p.fazi@gimema.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date November 2026
Est. primary completion date November 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
peripheral blood and bone marrow withdrawal
samples evaluation

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary B-cell mediated disease incidence evaluation of percentage of patients with a predominant B-cell mediated disease at baseline
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