Back to resultsBiologic Characterization of Patients With ITP
Primary Purpose
Immune Thrombocytopenia
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
peripheral blood and bone marrow withdrawal
Sponsored by
About this trial
This is an interventional basic science trial for Immune Thrombocytopenia
Eligibility Criteria
Inclusion Criteria: 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. 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Biological evaluation
Arm Description
characterization of biological features of enrolled ITP patients
Outcomes
Primary Outcome Measures
B-cell mediated disease incidence
evaluation of percentage of patients with a predominant B-cell mediated disease
Secondary Outcome Measures
Full Information
NCT ID
NCT05694325
First Posted
January 12, 2023
Last Updated
January 12, 2023
Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
1. Study Identification
Unique Protocol Identification Number
NCT05694325
Brief Title
Biologic Characterization of Patients With ITP
Official Title
Biologic Characterization of Patients With Immune Thrombocytopenia (ITP)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
March 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Biological evaluation
Arm Type
Other
Arm Description
characterization of biological features of enrolled ITP patients
Intervention Type
Other
Intervention Name(s)
peripheral blood and bone marrow withdrawal
Intervention Description
samples evaluation
Primary Outcome Measure Information:
Title
B-cell mediated disease incidence
Description
evaluation of percentage of patients with a predominant B-cell mediated disease
Time Frame
at baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paola Fazi
Phone
0670390528
Email
p.fazi@gimema.it
First Name & Middle Initial & Last Name or Official Title & Degree
Enrico Crea
Phone
0670390514
Email
e.crea@gimema.it
12. IPD Sharing Statement
Learn more about this trial
Biologic Characterization of Patients With ITP
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