Primary Immune ThrombocytopeniaNCT06071520
Andalusian Experience in the Use of Fostamatinib in Patients With ITP. FOSTASUR Study
An observational study of Primary Immune Thrombocytopenia, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 14 sites in Spain.
Trial summary
Description of the use of fostamatinib in patients with PTI in the Andalusian region. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Immune Thrombocytopenia
- What is being tested?
- Fostamatinib
- How many people
- 50 participants
- Where
- 14 sitesSpain
- Study dates
- 1 Mar 2023to 30 Jun 2023
- 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: Patients treated with fostamatinib for ITP between October 2021 (marketing date in Spain) and December 2022 in the Andalusian region.
Who may be able to join
- Patients aged 18 years or older.
- Patients with ITP criteria according to clinical practice guidelines.
Who cannot join
- Patients with any medical or psychological condition that prevents them from following the procedures of normal clinical practice as determined by the investigator.
- Subjects with other concomitant hemostatic defects.
- Documented history or clinical evidence of medical conditions (other than ITP) that consider the underlying cause of thrombocytopenia.
- Diagnosis of secondary immune thrombocytopenia.
- Subject has a known allergy to fostamatinib or any of the ingredients included in its formulation.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Spain14 sites
Hospital Puerta del Mar
Cadiz, Cádiz, 11009
Hospital Universitario Virgen de las Nieves
Granada, 18014
Hospital Universitario San Cecilio
Granada, 18016
Hospital Universitario Juan Ramón Jiménez
Huelva, 21005
Hospital Universitario de Jaén
Jaén, 23007
Hospital Universitario de Jerez de la Frontera
Jerez de la Frontera, Cádiz, 11407
Hospital Regional Universitario de Málaga
Málaga, 29010
Hospital Virgen de la Victoria
Málaga, 29010
Hospital de Riotinto
Minas de Ríotinto, Huelva, 21660
Hospital de la Merced de Osuna
Osuna, Sevilla, 41640
Hospital de Puerto Real
Puerto Real, Cádiz, 11510
Hospital de la Serranía de Ronda
Ronda, Málaga, 29400
Hospital Universitario Virgen Macarena
Seville, 41009
Hospital Universitario Virgen del Rocío
Seville, 41013
About this study
Description of the use of fostamatinib in patients with PTI in the Andalusian region.
Read the detailed description
Fostamatinib is a splenic tyrosine kinase (SYK) inhibitor whose indications include the treatment of chronic primary immune thrombocytopenia (PTI) refractory to first-line treatments. Data from two phase 3 studies in PTI, together with supporting safety data from a comprehensive program in 3,437 subjects with rheumatoid arthritis, led to the approval and registration of fostamatinib by health authorities in the US and in Europe.
Given the recent commercialization of fostamatinib for PTI, there is little data in real clinical practice that helps its general management: how to perform tapering, response rates in less refractory patients, experience in subjects with associated immunosuppressive therapies or thrombopoietin analogues, etc. These studies outside the clinical trial environment are relevant to plan needs, consumption, efficacy, and safety results in real clinical practice in our environment, the Andalusian region. The pivotal studies present experience on 102 cases and the real-life experience is of case series of less than 5 patients, with the population of patients treated in the Andalusian region as of December 31st being greater than 40 cases. For all these reasons the Andalusian Group of Congenital Coagulopathies proposes collecting what the experience has been like in their environment. Participation in this study is not intended to change the routine treatment patients receive as determined by their prescribing physicians. No clinic visits, procedures, evaluations, or tests will be required for the purposes of the study. This is multicenter retrospective data that will be collected from information generated during routine examinations and treatments performed by the investigator according to the standard of care.
- Conditions
- Primary Immune Thrombocytopenia
- 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
Also called Andalusian PTI fostamatinib patients
Patient treated with fostamatinib in the period described
| Study group | Role | What they receive |
|---|---|---|
| PTI patients treated with fostamatinib | Patient with criteria of PTI who has been treated with fostamatinib in the time described Receives: Drug: Fostamatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of fostamatinib use
Description of dose and treatment duration of fostamatinib in patients primary immune thrombocytopenia (PTI)
Measured: From fostamatinib prescription first date
Secondary outcomes (9)
Response
Platelets count greater than 30x10^9/L and greater than 50X10^9/L at least once during treatment in the absence of combination treatment or rescue therapy.
Measured: Whenever it occurs after the start of treatment with fostamatinib
Response duration
Duration in weeks of response greater than 30x10^9/L, 50x10^9/L and 100x10^9/L.
Measured: Whenever it occurs after the start of treatment with fostamatinib
Response failure rate
Platelets count less than 30x10^9/L after four weeks of treatment.
Measured: Whenever it occurs after the start of treatment with fostamatinib
Efficiency
Identify situations that limits the effectiveness of fostamatinib.
Measured: Whenever it occurs after the start of treatment with fostamatinib
Rescue treatment
Percentage of patients who required rescue therapy.
Measured: Whenever it occurs after the start of treatment with fostamatinib
Associated therapies
Percentage of patients who have required therapy for ITP associated with fostamatinib.
Measured: Whenever it occurs after the start of treatment with fostamatinib
Bleeding
Description of hemorrhagic events.
Measured: Whenever it occurs after the start of treatment with fostamatinib
Side effects
Description of side effects associated with the use of fostamatinib.
Measured: Whenever it occurs after the start of treatment with fostamatinib
Security
Number of emergencies, unscheduled visits or hospitalizations for PTI related causes during treatment with fostamatinib.
Measured: Whenever it occurs after the start of treatment with fostamatinib
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start1 Mar 2023
- Primary completion1 Apr 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- María Eva Mingot Castellano, MD-PhD, Principal investigator, Universisty Hospital Virgen del Rocío
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071520
- Sponsor's protocol ID
- FOSTASUR
- Status last verified
- Oct 2023
- First submitted
- 3 Oct 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Summaries or oral presentations will be presented with descriptive, preliminary results, by subgroups and finals of the study at international and national congresses of Hematology Societies.
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Andalusian Experience in the Use of Fostamatinib in Patients With ITP. FOSTASUR Study
- ClinicalTrials.gov ID
- NCT06071520
- Acronym / sponsor ID
- FOSTASUR
- Conditions
- Primary Immune Thrombocytopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 6 Oct 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.
Description of the use of fostamatinib in patients with PTI in the Andalusian region.
Detailed description
Fostamatinib is a splenic tyrosine kinase (SYK) inhibitor whose indications include the treatment of chronic primary immune thrombocytopenia (PTI) refractory to first-line treatments. Data from two phase 3 studies in PTI, together with supporting safety data from a comprehensive program in 3,437 subjects with rheumatoid arthritis, led to the approval and registration of fostamatinib by health authorities in the US and in Europe.
Given the recent commercialization of fostamatinib for PTI, there is little data in real clinical practice that helps its general management: how to perform tapering, response rates in less refractory patients, experience in subjects with associated immunosuppressive therapies or thrombopoietin analogues, etc. These studies outside the clinical trial environment are relevant to plan needs, consumption, efficacy, and safety results in real clinical practice in our environment, the Andalusian region. The pivotal studies present experience on 102 cases and the real-life experience is of case series of less than 5 patients, with the population of patients treated in the Andalusian region as of December 31st being greater than 40 cases. For all these reasons the Andalusian Group of Congenital Coagulopathies proposes collecting what the experience has been like in their environment. Participation in this study is not intended to change the routine treatment patients receive as determined by their prescribing physicians. No clinic visits, procedures, evaluations, or tests will be required for the purposes of the study. This is multicenter retrospective data that will be collected from information generated during routine examinations and treatments performed by the investigator according to the standard of care.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PTI patients treated with fostamatinib | – | Drug: FostamatinibPatient with criteria of PTI who has been treated with fostamatinib in the time described |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with fostamatinib for ITP between October 2021 (marketing date in Spain) and December 2022 in the Andalusian region.
Key inclusion criteria (2 listed)
- Patients aged 18 years or older.
- Patients with ITP criteria according to clinical practice guidelines.
Key exclusion criteria (5 listed)
- Patients with any medical or psychological condition that prevents them from following the procedures of normal clinical practice as determined by the investigator.
- Subjects with other concomitant hemostatic defects.
- Documented history or clinical evidence of medical conditions (other than ITP) that consider the underlying cause of thrombocytopenia.
- Diagnosis of secondary immune thrombocytopenia.
- Subject has a known allergy to fostamatinib or any of the ingredients included in its formulation.
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 |
|---|---|---|
| FostamatinibAlso: Andalusian PTI fostamatinib patientsPatient treated with fostamatinib in the period described | Drug | PTI patients treated with fostamatinib |
Primary outcome
Description of fostamatinib use
Time frame: From fostamatinib prescription first date
Description of dose and treatment duration of fostamatinib in patients primary immune thrombocytopenia (PTI)
9 secondary outcomes
Response
Time frame: Whenever it occurs after the start of treatment with fostamatinib
Response duration
Time frame: Whenever it occurs after the start of treatment with fostamatinib
Response failure rate
Time frame: Whenever it occurs after the start of treatment with fostamatinib
Efficiency
Time frame: Whenever it occurs after the start of treatment with fostamatinib
Rescue treatment
Time frame: Whenever it occurs after the start of treatment with fostamatinib
Associated therapies
Time frame: Whenever it occurs after the start of treatment with fostamatinib
Bleeding
Time frame: Whenever it occurs after the start of treatment with fostamatinib
Side effects
Time frame: Whenever it occurs after the start of treatment with fostamatinib
Security
Time frame: Whenever it occurs after the start of treatment with 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 17 Oct 2023.
- Individual participant dataSharing planned: Yes. Summaries or oral presentations will be presented with descriptive, preliminary results, by subgroups and finals of the study at international and national congresses of Hematology Societies.
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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.
María Eva Mingot Castellano, MD-PhD principal investigator
Universisty Hospital Virgen del Rocío
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Immune Thrombocytopenia, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 14 sites in Spain.
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 2 inclusion and 5 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 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Spain. 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?
Description of fostamatinib use (time frame: From fostamatinib prescription first date). 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 17 Oct 2023.