NCT03764618

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of wAIHA

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Rigel Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess the efficacy of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).

Conditions

• Warm Antibody Autoimmune Hemolytic Anemia

Interventions

Type	Name	Description
DRUG	Fostamatinib disodium	Fostamatinib (100mg PO bid or 150 mg PO bid) The dose may be reduced at any time to a dose as low as fostamatinib 100 mg PO qd or matching placebo if dose limiting adverse events are observed.
DRUG	Placebo	Placebo

Timeline

• Start date: 2019-04-24
• Primary completion: 2022-04-11
• Completion: 2022-04-11
• First posted: 2018-12-05
• Last updated: 2023-05-25
• Results posted: 2023-05-25

Locations

102 sites across 22 countries: United States, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Czechia, Denmark, France, Georgia, Germany, Hungary, Italy, Netherlands, Norway, Romania, Russia, Serbia, Spain, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study