Recombinant Factor VIIa in Acute Intracerebral Haemorrhage
NCT00127283 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 829
Last updated 2017-01-12
Summary
This trial is conducted in Asia, Europe, Middle East, North America, Oceania, and South America.
The purpose of this study is to evaluate the treatment of Recombinant Factor VIIa (eptacog alfa (activated)) in patients with acute intracerebral bleeding. It is expected that more patients will recover without severe permanent disability after acute treatment with Recombinant Factor VIIa by reducing further intracerebral bleeding.
Conditions
- Acquired Bleeding Disorder
- Intracerebral Haemorrhage
Interventions
- DRUG
-
eptacog alfa (activated)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-05-31
- Primary Completion
- 2007-01-31
- Completion
- 2007-01-31
Countries
- United States
- Australia
- Austria
- Belgium
- Brazil
- Canada
- China
- Croatia
- Denmark
- Finland
- France
- Germany
- Hong Kong
- Israel
- Italy
- Netherlands
- Norway
- Singapore
- Spain
- Sweden
- Switzerland
- Taiwan
- Thailand
Study Locations
More Related Trials
-
Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding Due to Trauma
NCT00323570 ·Status: WITHDRAWN ·Phase: PHASE3
-
Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII for Preventing Early Hematoma Growth in Acute Intracerebral Haemorrhage
NCT01563445 ·Status: COMPLETED ·Phase: PHASE2
-
Activated Recombinant Human Factor VII Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease
NCT01562574 ·Status: COMPLETED ·Phase: PHASE3
-
Recombinant Factor VIIa (NovoSeven) on Restoring Coagulation Activation
NCT00375323 ·Status: COMPLETED ·Phase: PHASE3
-
Observational Study Describing the Usual Clinical Practice Use of NovoSeven® in the Home Treatment of Joint Bleeds in Patients With Haemophilia A or B and Inhibitors
NCT01234545 ·Status: COMPLETED
-
Efficacy of Activated Recombinant Human Factor VII in Healthy Volunteers Treated for Punch Biopsy Mediated Bleeding
NCT01561950 ·Status: TERMINATED ·Phase: PHASE1
-
Observational Study on the Efficacy and Safety of NovoSeven® During "Real-life" Usage in Germany
NCT00697320 ·Status: COMPLETED
-
Prediction of the Efficacy of Activated Recombinant Human Factor VII in Adult Congenital Haemophilia A or B Patients With Inhibitors by Use of Thromboelastography
NCT01561924 ·Status: COMPLETED ·Phase: PHASE1
-
Haemophilia Patients With Inhibitors Being Treated for Acute Joint Bleeds
NCT00486278 ·Status: COMPLETED ·Phase: PHASE2
-
Dose Response to Recombinant Factor VIIa When Administered for Bleed
NCT00104455 ·Status: COMPLETED ·Phase: PHASE1
-
Observational Registry of NovoSeven® Used as On-demand Treatment of Bleeds in Patients With Haemophilia A and B With Inhibitors
NCT00703911 ·Status: COMPLETED
-
Efficacy of NovoSeven® in Bleeding Prophylaxis in Hemophilia
NCT00108758 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Allogeneic Stem Cell Transplantation
NCT01562158 ·Status: COMPLETED ·Phase: PHASE2
-
Observational Study on Safety of Room Temperature Stable NovoSeven® in Patients With Haemophilia A or B
NCT01220141 ·Status: COMPLETED
-
Clinical Study of Recombinant Human Activated Coagulation Factor VII for Injection in Patients With Hemophilia With Inhibitor
NCT05487976 ·Status: UNKNOWN ·Phase: PHASE3
-
Trial of NovoSeven® in Haemophilia - Joint Bleeds
NCT00108797 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Hematopoietic Stem Cell Transplantation
NCT01564563 ·Status: TERMINATED ·Phase: PHASE2
-
Recombinant Factor VIIa BI (rFVIIa BI) Treatment of Acute Bleeding Episodes Per an On-demand Regimen
NCT01757405 ·Status: COMPLETED ·Phase: PHASE3
-
Observational Study on the Use of NovoSeven® for Haemostatic Treatment of Bleeding Episodes in Patients With Acquired Haemophilia
NCT01285089 ·Status: COMPLETED
-
Safety and Tolerability of Intravenous Doses of Activated Recombinant Human Factor VII in Healthy Volunteers
NCT01563471 ·Status: COMPLETED ·Phase: PHASE1
-
PROPACT: Retrospective Prophylaxis Patient Case Collection
NCT00882778 ·Status: COMPLETED
-
Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non- Bleeding State
NCT01562587 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Efficacy of 3 Different Doses of Long Acting Factor VII in Haemophilia A or B Patients With Inhibitors
NCT00951405 ·Status: COMPLETED ·Phase: PHASE2
-
Treatment of Congenital Factor VII Deficiency
NCT01779921 ·Status: COMPLETED
-
Phase III Study of Coagulation FVIIa (Recombinant) in Congenital Hemophilia A or B Patients With Inhibitors
NCT02020369 ·Status: COMPLETED ·Phase: PHASE3