Characterizing biological aspects of untreated ITP patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Sirolimus added to standard therapy for adults with SLE-associated immune thrombocytopenia

  This trial tests whether adding sirolimus to usual treatment helps adults with SLE-related immune thrombocytopenia see their platelet counts improve.

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• GL-2045 safety and blood-count help for adults with ITP

  GL-2045 is being tested in adults with immune thrombocytopenia to see if it can safely raise platelet counts like IVIg does.

  Recruiting Phase 1 Gliknik Inc. · Leeds · NCT07605845

• Eltrombopag use in adults with primary ITP: real-world patterns and outcomes

  This study looks at how eltrombopag is used in adult patients with primary ITP and what outcomes are seen in routine care.

  Recruiting Novartis · Basel · NCT07587723

• Daratumumab versus rituximab for children with primary immune thrombocytopenia

  This study will test whether daratumumab works better than rituximab to increase platelet counts in children aged 6–17 with primary ITP who did not respond to or relapsed after steroid treatment.

  Recruiting Phase 2 Institute of Hematology & Blood Diseases Hospital, China · Tianjin · NCT07362238

• Daratumumab plus rituximab for adults with relapsed or refractory immune thrombocytopenia

  This treatment combines daratumumab (an anti‑CD38 antibody) with rituximab to see if it raises platelet counts in adults with ITP who haven't responded to steroids and other therapies.

  Recruiting Phase 2 Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality · NCT07362199

• Daratumumab versus rituximab for adult primary immune thrombocytopenia

  This trial will test whether daratumumab (an anti‑CD38 antibody) works better than rituximab for adults with primary ITP who did not respond to or relapsed after steroid treatment.

  Recruiting Phase 2 Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality · NCT07297563

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.