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

Rigel Pharmaceuticals

Status: Terminated

Conditions: ITP; Immune Thrombocytopenia

Treatments: Drug: Fostamatinib

Study type: Observational

Funder types: Industry

Identifiers

NCT04904276

O-FOSTA-901

Details and patient eligibility

About

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).

Full 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).

Enrollment: 16 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

16 participants in 2 patient groups

Initiating treatment with fostamatinib as second-line therapy

Treatment:

Drug: Fostamatinib

Treated with fostamatinib for at least 12 weeks as second-line therapy

Treatment:

Drug: Fostamatinib