drugset / Trial / NCT03700723

Comparison of the Efficacy & Safety of Resusix With FP24 in Patients With Acquired Coagulopathy

NCT03700723 ↗

Phase 2 Terminated 4 enrolled Entegrion, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

Phase 2a study to assess the safety and efficacy of IV infused spray-dried solvent/detergent -treated plasma (Resusix) when compared with an equal volume of plasma frozen within 24 hours after phlebotomy (FP24) in patients with liver disease who are actively bleeding or who require prophylaxis for surgical bleeding

Timeline

Start
2018-12-14
Primary completion
2020-04-15
Completion
2020-04-15

Outcome

Outcome not reported

Stopped (Business): “Convenience of Government Funding Sponsor”

Drugs

EvaluationDrugModalityDoseRoute
Comparator FP24 Unknown 1 unknown Intravenous
Comparator FP24 Unknown 2 unknown Intravenous
Comparator FP24 Unknown 3 unknown Intravenous
Comparator FP24 Unknown 4 unknown Intravenous
Subject Resusix Unknown 1 unknown Intravenous
Subject Resusix Unknown 2 unknown Intravenous
Subject Resusix Unknown 3 unknown Intravenous
Subject Resusix Unknown 4 unknown Intravenous