Print

Purpose

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).

Conditions

Eligibility

Eligible Ages
Between 18 Years and 100 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Initiating treatment with fostamatinib as second-line therapy
  • Drug: Fostamatinib
    Fostamatinib disodium
Treated with fostamatinib for at least 12 weeks as second-line therapy
  • Drug: Fostamatinib
    Fostamatinib disodium

More Details

Status
Terminated
Sponsor
Rigel Pharmaceuticals

Study Contact

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 who have an insufficient response to prior therapy (steroids ± immunoglobulins).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.