Dose-Response in PD and Safety of Cofact Under VKA Anticoagulation

NCT05205863 ↗

Phase 1/2 Completed 69 enrolled Prothya Biosolutions PRA Health Sciences · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomized, open label, placebo-controlled, parallel design, single center, prospective study. Subjects will receive treatment with VKA. Subjects who reach the targeted INR, will receive single dose of Cofact. Multiple coagulation laboratory tests will be evaluated over a period of 15 days

Timeline

Start: 2021-11-12
Primary completion: 2022-08-20
Completion: 2022-09-03

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cofact	Protein / enzyme biologic	—	—

Indications

No indication recorded.