A Efficacy and Safety Study of R935788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)

NCT02076399 ↗

Phase 3 Completed 76 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: 2014-07-14
Primary completion: 2016-04-21
Completion: 2016-04-21

Outcome

Met primary endpoint

registry analysis (superiority test); Fostamatinib Recipient vs Placebo Recipient; p = 0.0261; Risk Difference (RD) 17.6 (95% CI 7.2 to 28.1); Fisher Exact NCT02076399 ↗

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