A Efficacy and Safety Study of Fostamatinib in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)

NCT02076412 ↗

Phase 3 Completed 74 enrolled Rigel Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of persistent/chronic Immune Thrombocytopenic Purpura (ITP).

Timeline

Start: 2015-01
Primary completion: 2016-08
Completion: 2016-08

Outcome

Missed primary endpoint

registry analysis (superiority test); Fostamatinib Recipient; p = 0.1519; Risk Difference (RD) 13.8 (95% CI 0.5 to 27.1); Fisher Exact NCT02076412 ↗

Publications

Cooper N, Altomare I, Thomas MR, Nicolson PLR, Watson SP, Markovtsov V, Todd LK, Masuda E, Bussel JB. Assessment of thrombotic risk during long-term treatment of immune thrombocytopenia with fostamatinib. Ther Adv Hematol. 2021 Apr 30;12:20406207211010875. doi: 10.1177/20406207211010875. eCollection 2021.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fostamatinib	Small molecule	100 mg	Oral
Subject	Fostamatinib	Small molecule	150 mg	Oral