A Phase 2, Multi-Center, Open Label, Simon Two-Stage Study to Evaluate the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (SOAR)

NCT02612558 Phase 2 COMPLETED

The purpose of this study is to evaluate whether fostamatinib is safe and effective in the treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA).

Details

Lead sponsor	Rigel Pharmaceuticals
Phase	Phase 2
Status	COMPLETED
Enrolment	26
Start date	2016-07
Completion	2019-12

Conditions

• Warm Antibody Autoimmune Hemolytic Anemia

Interventions

• Fostamatinib 150 mg bid

Primary outcomes

• Hemoglobin response — by Week 24
  Hemoglobin level of \> 10 g/dL and 2 g/dL higher than the baseline hemoglobin

Countries

United States, Canada