Fostamatinib for Warm Antibody Autoimmune Hemolytic Anemia (wAIHA)

This study is testing the long-term safety of a drug called fostamatinib disodium for people with warm antibody autoimmune hemolytic anemia (wAIHA). wAIHA is a condition where your body's immune system mistakenly attacks and destroys your red blood cells. Fostamatinib disodium comes in 100 mg and 150 mg doses. The study aims to see how safe fostamatinib is over time by tracking side effects, blood pressure, and a type of white blood cell called Absolute Neutrophil Count (ANC) for up to 104 weeks. You can join if you are 18 to 100 years old and have already completed 24 weeks of a previous study (C-935788-057) with this drug. The study plans to enroll 90 participants, but its current status is unclear.

Study design
This is an open-label study, meaning you and your doctors will know you are receiving fostamatinib disodium. It plans to include 90 participants.
What's involved
To join, you must have completed 24 weeks of a previous study (C-935788-057). The study will track your safety for up to 104 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be followed for up to 104 weeks, measuring adverse events, blood pressure, and Absolute Neutrophil Count (ANC).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04138927

A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

Enrolling by Invitation
PHASE3Ages 18+InterventionalTreatment
Rigel Pharmaceuticals
~90 participants
Updated 2022-03-17 on ClinicalTrials.gov
What's tested:Fostamatinib disodium

At a glance

Recruiting sites
0 of 37 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse Events
Measured over 104 weeks
+2 more outcomes measured
Warm Antibody Autoimmune Hemolytic Anemia
37 sites across 24 states
Bulgaria3
Italy3
California2
Washington2
Austria2
Belarus2
Czechia2
Georgia2

This trial hasn't published a contact. View it on ClinicalTrials.gov

  • Adverse Events104 weeks

    Incidence, frequency, seriousness, and severity of adverse events that occurred during the current study

  • Blood Pressure104 weeks

    Change from baseline in blood pressure over time

  • Absolute Neutrophil Count (ANC)104 weeks

    Change from baseline in absolute neutrophil count (ANC) over time