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NCT05694325 | RECRUITING | Immune Thrombocytopenia

Biologic Characterization of Patients With ITP
Sponsor:

Italian Group of Adult Hematological Diseases

Brief 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.

Condition or disease

Immune Thrombocytopenia

Intervention/treatment

peripheral blood and bone marrow withdrawal

Phase

NA

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 200 participants
Masking : NONE
Primary Purpose : BASIC_SCIENCE
Official Title : Biologic Characterization of Patients With Immune Thrombocytopenia (ITP)
Actual Study Start Date : 2023-11-27
Estimated Primary Completion Date : 2026-11
Estimated Study Completion Date : 2026-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Biologic Characterization of Patients With ITP

Location Details

NCT05694325

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Italy,

Hematology UOC AOU of Bologna

Bologna, Italy,

RECRUITING

Italy,

Hematology and transplant center ASL Piacenza

Piacenza, Italy,

RECRUITING

Italy,

Hematology A. Gemelli University Hospital

Roma, Italy,

RECRUITING

Italy,

Sc Hematology S.G. Hospital Battista Molinette - University of Turin

Torino, Italy,

RECRUITING

Italy,

SC Hematology ASUGI

Trieste, Italy,