Biologic Characterization of Patients With ITP

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-27

Study Completion Date

2026-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Immune Thrombocytopenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Biological evaluation

characterization of biological features of enrolled ITP patients

Group Type OTHER

peripheral blood and bone marrow withdrawal

Intervention Type OTHER

samples evaluation

Interventions

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peripheral blood and bone marrow withdrawal

samples evaluation

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No