CLINICAL TRIALS PROFILE FOR PROTHROMBIN COMPLEX CONCENTRATE (HUMAN)
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All Clinical Trials for prothrombin complex concentrate (human)
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00166309 ↗ | The FEIBA NovoSeven Comparative Study | Completed | Skane University Hospital | N/A | 2000-07-01 | FENOC is a prospective, open-label, randomized, cross-over, multi-center study to investigate and compare the hemostatic effect and cost-efficacy of two different by-passing agents in the treatment of joint hemorrhages in subjects with severe hemophilia A and inhibitors. The study is designed as a clinical equivalency trial. |
| NCT00168077 ↗ | Prothrombin Complex Concentrate for Anticoagulant Reversal | Completed | CSL Behring | Phase 3 | 2005-09-01 | Patients on oral anticoagulants need rapid reversal of the anticoagulant effect in case of acute bleeding or emergency surgery. Prothrombin Complex Concentrates are known to provide a fast reversal of the anticoagulant effect, with several advantages over alternatives like vitamin K or FFP.The planned clinical Phase III study is designed to provide clinically relevant data on efficacy and safety. |
| NCT00221195 ↗ | Efficacy Study of Activated Prothrombin Complex for Prevention of Bleeds in Hemophilia A With Inhibitors | Completed | Tulane University School of Medicine | Phase 2/Phase 3 | 2003-06-01 | The objective of this study is to assess whether prophylactic therapy with an activated prothrombin complex concentrate (FEIBA)will result in a significant reduction in the number of bleeds in patients with hemophilia and persistent high responding inhibitors. |
| NCT00770718 ↗ | Factor VII, Prothrombin Complex Concentrate, and Fresh Frozen Plasma in Warfarin-Related Intracranial Hemorrhage | Terminated | Sheila B. Terry Memorial Research Fund | Phase 1 | 2008-04-01 | The purpose of this dose-ranging pilot study is to compare Recombinant Activated Factor VII, Prothrombin Complex Concentrate and Fresh Frozen Plasma (each starting at low doses with escalation if necessary) for the reversal of warfarin in the setting of acute intracranial hemorrhage. |
| NCT00770718 ↗ | Factor VII, Prothrombin Complex Concentrate, and Fresh Frozen Plasma in Warfarin-Related Intracranial Hemorrhage | Terminated | University of Utah | Phase 1 | 2008-04-01 | The purpose of this dose-ranging pilot study is to compare Recombinant Activated Factor VII, Prothrombin Complex Concentrate and Fresh Frozen Plasma (each starting at low doses with escalation if necessary) for the reversal of warfarin in the setting of acute intracranial hemorrhage. |
| NCT01210755 ↗ | Study in Healthy Volunteers of the Reversion by Haemostatic Drugs of the Anticoagulant Effect of New Anti-thrombotics | Completed | University Hospital, Grenoble | Phase 4 | 2010-11-01 | The purpose of this study is to evaluate whether the effect of the two new anticoagulants, Dabigatran and Rivaroxaban, can be reversed by non-specific and specific inhibitors. For Dabigatran the investigators will test the non-specific inhibitors: prothrombin complex concentrate (PCC), recombinant activated coagulation factor VII, and activated prothrombin-complex (FEIBA). For Rivaroxaban the investigators will test a specific Rivaroxaban decoy (FXa-GLAless). This will be done in a laboratory using blood plasma from healthy male volunteers. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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