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

NCT04138927 Phase 3 ENROLLING_BY_INVITATION

The primary objective of this study is: • To evaluate the long-term safety of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).

Details

Lead sponsor	Rigel Pharmaceuticals
Phase	Phase 3
Status	ENROLLING_BY_INVITATION
Enrolment	90
Start date	2019-10-30
Completion	2024-04

Conditions

• Warm Antibody Autoimmune Hemolytic Anemia

Interventions

• Fostamatinib disodium

Primary outcomes

• Adverse Events — 104 weeks
  Incidence, frequency, seriousness, and severity of adverse events that occurred during the current study
• Blood Pressure — 104 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

Countries

United States, Australia, Austria, Belarus, Belgium, Bulgaria, Czechia, France, Georgia, Germany, Italy, Netherlands, Norway, Russia, Serbia, Spain, Ukraine, United Kingdom