Characterizing biological aspects of untreated ITP patients
Biologic Characterization of Patients With Immune Thrombocytopenia (ITP)
This study is trying to learn more about untreated primary Immune Thrombocytopenia (ITP) by looking at blood and other samples from patients who are starting their first treatment to see how their condition changes over time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gruppo Italiano Malattie EMatologiche dell'Adulto Academic / other |
| Locations | 5 sites (Bologna and 4 other locations) |
| Trial ID | NCT05694325 on ClinicalTrials.gov |
What this trial studies
This multicenter, non-profit study aims to biologically characterize patients with previously untreated primary Immune Thrombocytopenia (ITP) who require first-line therapy. It involves collecting peripheral blood, fecal, and bone marrow samples at baseline, and again at 30 and 180 days after treatment initiation. The biological analyses performed on these samples will be compared to observe changes related to the disease's natural history and the effects of the administered therapy. The study seeks to enhance understanding of ITP and its treatment responses.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with previously untreated primary ITP requiring first-line therapy.
Not a fit: Patients with secondary ITP or those who have already started first-line therapy due to life-threatening bleeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with ITP based on biological insights.
How similar studies have performed: While this approach is focused on biological characterization, similar studies in other hematological conditions have shown promise in understanding disease mechanisms and treatment responses.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bologna and 4 other locations
- UOC ematologia AOU di Bologna — Bologna, Italy (Recruiting)
- Ematologia e centro trapianti ASL Piacenza — Piacenza, Italy (Recruiting)
- Ematologia Policlinico Universitario A.Gemelli — Roma, Italy (Recruiting)
- Sc Ematologia Ospedale S.G. Battista Molinette - Università Degli Studi Di Torino — Torino, Italy (Recruiting)
- SC Ematologia ASUGI — Trieste, Italy (Recruiting)
Study contacts
- Principal investigator: Elisa Lucchini — SC Ematologia ASUGI
- Study coordinator: Paola Fazi
- Email: p.fazi@gimema.it
- Phone: 0670390528
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.