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Enrolling By InvitationNCT04138927

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

Status
Enrolling By Invitation
Phase
Phase 3
Study type
Interventional
Enrollment
90 (estimated)
Sponsor
Rigel Pharmaceuticals · Industry
Sex
All
Age
18 Years – 100 Years
Healthy volunteers
Not accepted

Summary

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

Conditions

Interventions

TypeNameDescription
DRUGFostamatinib disodiumFostamatinib is supplied in two (2) dosage strengths: 100 mg and 150 mg.

Timeline

Start date
2019-10-30
Primary completion
2024-04-01
Completion
2024-04-01
First posted
2019-10-25
Last updated
2022-03-17

Locations

37 sites across 18 countries: United States, Australia, Austria, Belarus, Belgium, Bulgaria, Czechia, France, Georgia, Germany, Italy, Netherlands, Norway, Russia, Serbia, Spain, Ukraine, United Kingdom

Regulatory

Source: ClinicalTrials.gov record NCT04138927. Inclusion in this directory is not an endorsement.

A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Ane (NCT04138927) · Clinical Trials Directory