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

Rigel Pharmaceuticals16 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

ITP Immune Thrombocytopenia

Interventions

FostamatinibDRUG

Fostamatinib disodium

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Willing and able to provide written informed consent 2. Diagnosis of ITP in adult patients (≥ 18 years of age) with an insufficient response to steroids ± immunoglobulins and requiring a change in therapy 3. For Cohort 1, intent to initiate fostamatinib at enrollment as change in therapy 4. 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: 1. Any prior ITP therapy/treatment other than steroids ± immunoglobulins (e.g. rituximab, thrombopoietin receptor agonists (TPO), splenectomy) 2. Participation in any interventional study during the course of this study 3. Lack of historical platelet counts, at time of fostamatinib initiation for those entering Cohort 2 4. Pregnant and/or nursing

Locations (14)

Advanced Research

Tamarac, Florida, United States

Simmons Cancer Institute at Southern Illinois University

Springfield, Illinois, United States

University of Kansas Medical Center