NCT06071520

Brief Summary

Description of the use of fostamatinib in patients with PTI in the Andalusian region.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2023

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

1 month

First QC Date

October 3, 2023

Last Update Submit

October 13, 2023

Conditions

Primary Immune Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

  • Description of fostamatinib use

    Description of dose and treatment duration of fostamatinib in patients primary immune thrombocytopenia (PTI)

    From fostamatinib prescription first date

Secondary Outcomes (9)

  • Response

    Whenever it occurs after the start of treatment with fostamatinib

  • Response duration

    Whenever it occurs after the start of treatment with fostamatinib

  • Response failure rate

    Whenever it occurs after the start of treatment with fostamatinib

  • Efficiency

    Whenever it occurs after the start of treatment with fostamatinib

  • Rescue treatment

    Whenever it occurs after the start of treatment with fostamatinib

  • +4 more secondary outcomes

Study Arms (1)

PTI patients treated with fostamatinib

Patient with criteria of PTI who has been treated with fostamatinib in the time described

Drug: Fostamatinib

Interventions

FostamatinibDRUG

Patient treated with fostamatinib in the period described

Also known as: Andalusian PTI fostamatinib patients
PTI patients treated with fostamatinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients treated with fostamatinib for ITP between October 2021 (marketing date in Spain) and December 2022 in the Andalusian region.

You may qualify if:

  • Patients aged 18 years or older.
  • Patients with ITP criteria according to clinical practice guidelines.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Hospital Puerta del Mar

Cadiz, Cádiz, 11009, Spain

Location

Hospital Universitario de Jerez de la Frontera

Jerez de la Frontera, Cádiz, 11407, Spain

Location

Hospital de Puerto Real

Puerto Real, Cádiz, 11510, Spain

Location

Hospital de Riotinto

Minas de Ríotinto, Huelva, 21660, Spain

Location

Hospital de la Serranía de Ronda

Ronda, Málaga, 29400, Spain

Location

Hospital de la Merced de Osuna

Osuna, Sevilla, 41640, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain

Location

Hospital Universitario San Cecilio

Granada, 18016, Spain

Location

Hospital Universitario Juan Ramón Jiménez

Huelva, 21005, Spain

Location

Hospital Universitario de Jaén

Jaén, 23007, Spain

Location

Hospital Regional Universitario de Málaga

Málaga, 29010, Spain

Location

Hospital Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

fostamatinib

Condition Hierarchy (Ancestors)

Purpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaHemorrhagic DisordersAutoimmune DiseasesImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Officials

  • María Eva Mingot Castellano, MD-PhD

    Universisty Hospital Virgen del Rocío

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2023

First Posted

October 6, 2023

Study Start

March 1, 2023

Primary Completion

April 1, 2023

Study Completion

June 30, 2023

Last Updated

October 17, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

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.

Locations

ES(14)