drugset / Trial / NCT03700723
Comparison of the Efficacy & Safety of Resusix With FP24 in Patients With Acquired Coagulopathy
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |