NCT02612558

A Safety and Efficacy Study of R935788 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Rigel Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Warm Antibody Autoimmune Hemolytic Anemia

Interventions

Type	Name	Description
DRUG	Fostamatinib 150 mg bid	Fostamatinib 150 mg bid. The dose of Fostamatinib may be reduced at any time to as low as 100 mg PO once daily (qd) if dose limiting adverse events are observed.

Timeline

• Start date: 2016-07-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2015-11-24
• Last updated: 2021-07-21

Locations

36 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study