Biologic Characterization of Patients With ITP
ConditionImmune Thrombocytopenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGruppo Italiano Malattie EMatologiche dell'Adulto
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
peripheral blood and bone marrow withdrawal
Other interventionsamples evaluation
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Biological evaluationOther 1 intervention
Trial outcomes
Primary outcomes
1
B-cell mediated disease incidence
evaluation of percentage of patients with a predominant B-cell mediated disease
Time frame
at baselineSponsors and contacts
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Source ClinicalTrials.gov