Status:
TERMINATED
Observational Study of Fostamatinib as Second Line Therapy in Adult Patients With Immune Thrombocytopenia (ITP) and Insufficient Response to a Prior Therapy
Lead Sponsor:
Rigel Pharmaceuticals
Conditions:
ITP
Immune Thrombocytopenia
Eligibility:
All Genders
18-100 years
Brief 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 wh...
Detailed 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 wh...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 18 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 17 2022
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04904276
Start Date
May 18 2021
End Date
November 17 2022
Last Update
March 15 2024
Active Locations (14)
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1
Advanced Research
Tamarac, Florida, United States, 33321
2
Simmons Cancer Institute at Southern Illinois University
Springfield, Illinois, United States, 62702
3
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
4
Saint Agnes Hospital
Baltimore, Maryland, United States, 21229