Taking people in ItalyNo phase
Biologic Characterization of Patients With ITP
Key facts
- Who runs it
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Where
- Bologna, Piacenza, Roma, Torino, and Trieste, ItalySee the 5 sites
- Trial code
- Status
- Recruiting
- People taking part
- 200 people, planned
- Started
- 27 Nov 2023
- Expected to end
- Nov 2026
- Type of study
- Interventional
- Treatments tested
- peripheral blood and bone marrow withdrawal
- Record updated
- 21 May 2024
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- Patients with primary ITP, in need for first line treatment according to 2019 ITP consensus2
- 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
- Age ≥ 18 years
- Signed written informed consent according to ICH/EU/GCP and national local laws
Who cannot take part
- 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 in Italy
- UOC ematologia AOU di BolognaBologna, ItalyContact: Nicola VianelliTaking people
- Ematologia e centro trapianti ASL PiacenzaPiacenza, ItalyContact: Daniele VallisaTaking people
- Ematologia Policlinico Universitario A.GemelliRoma, ItalyContact: Valerio De StefanoTaking people
- Sc Ematologia Ospedale S.G. Battista Molinette - Università Degli Studi Di TorinoTorino, ItalyContact: Alessandra BorchielliniTaking people
- SC Ematologia ASUGITrieste, ItalyContact: Elisa LucchiniTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- Biological evaluationOther group
characterization of biological features of enrolled ITP patients
Treatment: peripheral blood and bone marrow withdrawal
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Biologic Characterization of Patients With Immune Thrombocytopenia (ITP)
- Record updated
- 21 May 2024