Trials / Terminated
TerminatedNCT03700723
Comparison of the Efficacy & Safety of Resusix With FP24 in Patients With Acquired Coagulopathy
Multicenter, Single-Blinded, Randomized, Comparator-Controlled Noninferiority Trial to Compare the Efficacy & Safety of Resusix With FP24 in Patients With Acquired Coagulopathy
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- Entegrion, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Resusix | spray-dried solvent/detergent treated plasma (blood product) |
| BIOLOGICAL | FP24 (Frozen Plasma) | plasma frozen within 24 hours of phlebotomy |
Timeline
- Start date
- 2018-12-14
- Primary completion
- 2020-04-15
- Completion
- 2020-04-15
- First posted
- 2018-10-09
- Last updated
- 2021-01-07
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03700723. Inclusion in this directory is not an endorsement.