ITP - Immune ThrombocytopeniaNCT05613296
Real World Evaluation of the Activity and Safety of Fostamatinib in Consecutive Adult Patients With ITP
An observational study of ITP - Immune Thrombocytopenia and Chronic ITP, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 21 sites in Italy.
Trial summary
This is a retrospective and prospective multicenter observational study with the aim to evaluate the real-life use of Fostamatinib in adult patients with chronic ITP, refractory to other treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ITP - Immune Thrombocytopenia, Chronic ITP, Refractory ITP
- What is being tested?
- Fostamatinib
- How many people
- 95 participants
- Where
- 21 sitesItaly
- Study dates
- 5 May 2023to 31 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: All adult ITP patients, refractory to other treatment, who received at least one dose of Fostamatinib between October 1st, 2021 and April 1st, 2023 outside interventional clinical trials in Italy in the participating Centers will be invited to participate in the study.
Who may be able to join
- Patients with chronic ITP who are refractory to other treatments and who received Fostamatinib according to standard clinical practice between October 1st, 2021 and April 1st, 2023
- Age greater or equal to 18 years at the treatment start
- Signed written informed consent document (if feasible) according to ICH/EU/GCP and national local laws
Who cannot join
- Contraindications or hypersensitivity to Fostamatinib, its active substance or any of its excipients
- Patients participating in an interventional clinical trial at the time of enrollment.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Italy21 sites
AON SS. ANTONIO E BIAGIO E C. ARRIGO - SS emostasi e trombosi
Alessandria
SOD Clinica Ematologica AOU Ospedali Riuniti Umberto I GM Lancisi G Salesi
Ancona
UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro
Bari
Istituto di Ematologia "Lorenzo e A. Seragnoli" Policlinico S. Orsola
Bologna
Asst Degli Spedali Civili Di Brescia - Uo Ematologia
Brescia
Unità di Onco-Ematologia - Azienda Ospedaliera Garibaldi
Catania
Ematologia A.O.U. Careggi
Florence
Milano Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia
Milan
Ematologia AOU Università degli Studi di Napoli "Federico II"
Naples
.C.D.U. Ematologia - Università del Piemonte Orientale Amedeo Avogadro
Novara
Aou Policlinico P. Giaccone Uo Ematologia
Palermo
Casa Di Cura La Maddalena S.P.A. - Dipartimento Oncologico Di Iii Livello - Uo Oncoematologia E Tmo
Palermo
Aou Pisana - Uo Ematologia Universitaria
Pisa
S.C. di Ematologia, Arcispedale Santa Maria Nuova I.R.C.C.S.
Reggio Emilia
Aou Policlinico Tor Vergata Uoc Trapianto Cellule Staminali
Roma
Fondazione P.U. Agostino Gemelli Irccs - Area Ematologica
Roma
Divisione di Ematologia "Città della Salute e della Scienza di Torino"
Torino
Azienda Ospedaliera "Cardinale G. Panico", Ematologia e Centro Trapianti midollo osseo
Tricase
Clinica Ematologica-Azienda Sanitaria Universitaria Integrata di Trieste
Trieste
Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia
Verona
ULSS N.6 Ospedale S. Bortolo - Ematologia
Vicenza
About this study
Official title: Real World Evaluation Among Italian Centers of the Activity and Safety of Fostamatinib in Consecutive Adult Patients With Immune Thrombocytopenia (ITP)
This is a retrospective and prospective multicenter observational study with the aim to evaluate the real-life use of Fostamatinib in adult patients with chronic ITP, refractory to other treatments.
Read the detailed description
This is a retrospective and prospective multicenter observational study with the aim to evaluate the real-life use of Fostamatinib in adult patients with chronic ITP, refractory to other treatments.
All patients who received at least one dose of Fostamatinib between October 1st, 2021 and April 1st, 2023 outside interventional clinical trials in Italy in the participating centers will be invited to participate in the study. Every patient will be observed for at least 6 months until October 1st, 2023.
- Conditions
- ITP - Immune Thrombocytopenia, Chronic ITP, Refractory ITP
- Being tested
- Fostamatinib
- 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.
FostamatinibDrug
Patients with Chronic ITP, refractory to other treatment who received at least one dose of Fostamatinib outside clinical trials in Italy will be enrolled and observed for at least 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Study group | All patients being observed during the study duration. Receives: Drug: Fostamatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ITP patients who receive Fostamatinib
effectiveness evaluation of fostamatinib
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start5 May 2023
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ITP - 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco Zaja, Principal investigator, Ematologia ASUGI Trieste
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613296
- Sponsor's protocol ID
- ITP1122
- Status last verified
- Apr 2025
- First submitted
- 4 Nov 2022
- Last updated
- 30 Apr 2025
- 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 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Evaluation Among Italian Centers of the Activity and Safety of Fostamatinib in Consecutive Adult Patients With Immune Thrombocytopenia (ITP)
- ClinicalTrials.gov ID
- NCT05613296
- Acronym / sponsor ID
- ITP1122
- Conditions
- ITP - Immune Thrombocytopenia, Chronic ITP, Refractory ITP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- 5 May 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 14 Nov 2022 (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 retrospective and prospective multicenter observational study with the aim to evaluate the real-life use of Fostamatinib in adult patients with chronic ITP, refractory to other treatments.
Detailed description
This is a retrospective and prospective multicenter observational study with the aim to evaluate the real-life use of Fostamatinib in adult patients with chronic ITP, refractory to other treatments.
All patients who received at least one dose of Fostamatinib between October 1st, 2021 and April 1st, 2023 outside interventional clinical trials in Italy in the participating centers will be invited to participate in the study. Every patient will be observed for at least 6 months until October 1st, 2023.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Drug: FostamatinibAll patients being observed during the study duration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult ITP patients, refractory to other treatment, who received at least one dose of Fostamatinib between October 1st, 2021 and April 1st, 2023 outside interventional clinical trials in Italy in the participating Centers will be invited to participate in the study.
Key inclusion criteria (3 listed)
- Patients with chronic ITP who are refractory to other treatments and who received Fostamatinib according to standard clinical practice between October 1st, 2021 and April 1st, 2023
- Age greater or equal to 18 years at the treatment start
- Signed written informed consent document (if feasible) according to ICH/EU/GCP and national local laws
Key exclusion criteria (2 listed)
- Contraindications or hypersensitivity to Fostamatinib, its active substance or any of its excipients
- Patients participating in an interventional clinical trial at the time of enrollment.
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 |
|---|---|---|
| FostamatinibPatients with Chronic ITP, refractory to other treatment who received at least one dose of Fostamatinib outside clinical trials in Italy will be enrolled and observed for at least 6 months. | Drug | Study group |
Primary outcome
Number of ITP patients who receive Fostamatinib
Time frame: 6 months
effectiveness evaluation of fostamatinib
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
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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. This study is not recruiting at the moment.
Francesco Zaja principal investigator
Ematologia ASUGI Trieste
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ITP - Immune Thrombocytopenia and Chronic ITP, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 21 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of ITP patients who receive Fostamatinib (time frame: 6 months). 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 30 Apr 2025.