Study of PER977 Administered to Subjects With Steady State Edoxaban Dosing and Re-anticoagulation With Edoxaban

NCT02207257 ↗

Phase 2 Completed 65 enrolled AMAG Pharmaceuticals, Inc. Quintiles, Inc. · collab

RandomizedSequentialSingle-blindOther

Summary

This study will evaluate the establishment of anticoagulation ("re-anticoagulation") of subjects with edoxaban following reversal by PER977 and will identify a dose regimen of PER977 that reverses the effects of edoxaban for up to 21 hours.

Timeline

Start: 2014-03
Primary completion: 2015-09
Completion: 2015-11

Publications

Sciascia S, Lopez-Pedrera C, Cecchi I, Pecoraro C, Roccatello D, Cuadrado MJ. Non-vitamin K antagonist oral anticoagulants and antiphospholipid syndrome. Rheumatology (Oxford). 2016 Oct;55(10):1726-35. doi: 10.1093/rheumatology/kev445. Epub 2016 Feb 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ciraparantag	Small molecule	25 mg	—
Subject	Ciraparantag	Small molecule	50 mg	—
Subject	Ciraparantag	Small molecule	100 mg	—
Subject	Ciraparantag	Small molecule	300 mg	—
Subject	Ciraparantag	Small molecule	600 mg	—
Subject	Edoxaban	Small molecule	60 mg	—

Indications

No indication recorded.