At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 90 enrolled
Drug / intervention
Fostamatinib disodium +1 moredrug
Likely dose
Fostamatinib disodium 100mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
In Brief
A Phase 3 clinical trial evaluating Fostamatinib disodium and Placebo for Warm Antibody Autoimmune Hemolytic Anemia. Completed, enrolled 90 participants across 102 sites in 22 countries.
Detailed Summary
The primary objective of this study is to assess the efficacy of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Austria, Belarus, Belgium, Bulgaria, Canada, Czechia, Denmark, France, Georgia, Germany, Hungary, Italy, Netherlands, Norway, Romania, Russia, Serbia, Spain, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedDec 2018
Enrollment StartApr 2019
Primary CompletionApr 2022
TodayJul 2026
First PostedDec 5, 2018
Enrollment StartApr 24, 2019
Primary CompletionApr 11, 2022
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 7.6 years ago
Interventions
Fostamatinib disodiumdrug
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.
Placebodrug
Placebo