Observational Study of Fostamatinib as Second Line Therapy in Adult Patients With Immune Thrombocytopenia (ITP) and Insufficient Response to a Prior Therapy

  • STATUS
    Recruiting
  • End date
    Dec 28, 2022
  • participants needed
    45
  • sponsor
    Rigel Pharmaceuticals
Updated on 28 July 2021
Investigator
Robert Numerof, Ph.D.
Primary Contact
Boston Medical Center (6.2 mi away) Contact
+7 other location
thrombocytopenia
immunoglobulins
immune globulin
fostamatinib

Summary

Evaluate patient characteristics, treatment patterns, clinical outcomes and safety of fostamatinib as second-line therapy in real-world clinical practice, for the treatment of ITP in adult patients who have an insufficient response to prior therapy (steroids immunoglobulins).

Description

Evaluate patient characteristics, treatment patterns, clinical outcomes and safety of fostamatinib as second-line therapy in real-world clinical practice, for the treatment of ITP in adult patients who have an insufficient response to prior therapy (steroids immunoglobulins).

Details
Condition IDIOPATHIC THROMBOCYTOPENIC PURPURA, Autoimmune disease, Inosine Triphosphate, Immune Thrombocytopenia, autoimmune thrombocytopenia
Treatment fostamatinib
Clinical Study IdentifierNCT04904276
SponsorRigel Pharmaceuticals
Last Modified on28 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Willing and able to provide written informed consent
Diagnosis of ITP in adult patients ( 18 years of age) with an insufficient response to steroids immunoglobulins and requiring a change in therapy
For Cohort 1, intent to initiate fostamatinib at enrollment as change in therapy
For Cohort 2, currently undergoing treatment with fostamatinib as second line therapy for at least 12 weeks, with the intent to continue, at the time of enrollment

Exclusion Criteria

Any prior ITP therapy/treatment other than steroids immunoglobulins (e.g. rituximab, thrombopoietin receptor agonists (TPO), splenectomy)
Participation in any interventional study during the course of this study
Lack of historical platelet counts, at time of fostamatinib initiation for those entering Cohort 2
Pregnant and/or nursing
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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