Immune ThrombocytopeniaNCT05694325
Biologic Characterization of Patients With ITP
A study testing peripheral blood and bone marrow withdrawal in people with Immune Thrombocytopenia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 5 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune Thrombocytopenia
- What is being tested?
- peripheral blood and bone marrow withdrawal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 5 sitesItaly
- Study dates
- 27 Nov 2023to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Italy5 sites, 5 recruiting
- Recruiting
UOC ematologia AOU di Bologna
Bologna
Nicola Vianelli
- Recruiting
Ematologia e centro trapianti ASL Piacenza
Piacenza
Daniele Vallisa
- Recruiting
Ematologia Policlinico Universitario A.Gemelli
Roma
Valerio De Stefano
- Recruiting
Sc Ematologia Ospedale S.G. Battista Molinette - Università Degli Studi Di Torino
Torino
Alessandra Borchiellini, studiclinici.coagulazione@gmail.com
- Recruiting
SC Ematologia ASUGI
Trieste
Elisa Lucchini
About this study
Official title: Biologic Characterization of Patients With Immune Thrombocytopenia (ITP)
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.
Read the 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.
- Conditions
- Immune Thrombocytopenia
- Being tested
- peripheral blood and bone marrow withdrawal
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peripheral blood and bone marrow withdrawalOther
samples evaluation
| Study group | Role | What they receive |
|---|---|---|
| Biological evaluation | Other | characterization of biological features of enrolled ITP patients Receives: Other: peripheral blood and bone marrow withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
B-cell mediated disease incidence
evaluation of percentage of patients with a predominant B-cell mediated disease
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start27 Nov 2023
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ThrombocytopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisa Lucchini, Principal investigator, SC Ematologia ASUGI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05694325
- Sponsor's protocol ID
- ITP1222
- Status last verified
- May 2024
- First submitted
- 12 Jan 2023
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biologic Characterization of Patients With Immune Thrombocytopenia (ITP)
- ClinicalTrials.gov ID
- NCT05694325
- Acronym / sponsor ID
- ITP1222
- Conditions
- Immune Thrombocytopenia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 23 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biological evaluation | Other | Other: peripheral blood and bone marrow withdrawalcharacterization of biological features of enrolled ITP patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peripheral blood and bone marrow withdrawalsamples evaluation | Other | Biological evaluation |
Primary outcome
B-cell mediated disease incidence
Time frame: at baseline
evaluation of percentage of patients with a predominant B-cell mediated disease
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elisa Lucchini principal investigator
SC Ematologia ASUGI
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing peripheral blood and bone marrow withdrawal in people with Immune Thrombocytopenia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 5 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paola Fazi (0670390528, p.fazi@gimema.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
B-cell mediated disease incidence (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.