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NCT00266006 Clinical Trial

Factor VIIa in Acute Intracerebral Haemorrhage

Acquired Bleeding Disorder Clinical Trial

Official title:
Safety of Eptacog Alfa (Activated) (Genetical Recombination) on Adverse Events and Serious Adverse Events in Patients With Acute Intracerebral Haemorrhage.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00266006
Other study ID # F7ICH-1602
Secondary ID JapicCTI-050194
Status Completed
Phase Phase 2
First received December 14, 2005
Last updated November 16, 2016
Start date January 2006
Est. completion date April 2007

Study information
Verified date November 2016
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

This trial is conducted in Japan. The purpose of this trial is to evaluate the safety and preliminary efficacy of Activated Recombinant Factor VII (NN-007) in patients with acute intracerebral haemorrhage.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date April 2007
Est. primary completion date April 2007
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Spontaneous ICH

Exclusion Criteria:

- Time of ICH onset > 3 hours

- Patients with secondary ICH

- Pre-existing disability

- Hemophilia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• eptacog alfa (activated)

Locations
Country Name City State
Japan Novo Nordisk Investigational Site Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary The Occurrence of thromboembolic serious adverse event Until 90 days No
Secondary Reducing disability and improving clinical outcome No
Secondary Reducing haematoma growth No
See also
  Status Clinical Trial Phase
Completed NCT01601457 - Activated Recombinant Human Factor VII in Pelvic-acetabular Fracture Reconstruction Phase 2
Completed NCT00124293 - Incidence/Magnitude-Haemorrhagic Progression-Cerebral Contusions and Identification (ID) of Safety Issues After Traumatic Brain Injury N/A
Terminated NCT00184548 - Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding Phase 3
Completed NCT02239146 - Safety of rFXIII in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass Phase 1
Completed NCT01563445 - Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII for Preventing Early Hematoma Growth in Acute Intracerebral Haemorrhage Phase 2
Withdrawn NCT00323570 - Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding Due to Trauma Phase 3
Completed NCT00127283 - Recombinant Factor VIIa in Acute Intracerebral Haemorrhage Phase 3
Completed NCT01563523 - Efficacy and Safety of Activated Recombinant Human Factor VII in Severely Injured Trauma Patients Phase 2
Terminated NCT01564563 - Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Hematopoietic Stem Cell Transplantation Phase 2
Completed NCT01153997 - Safety of Recombinant Factor XIII (rFXIII) in Healthy Japanese Volunteers Phase 1
Completed NCT00697320 - Observational Study on the Efficacy and Safety of NovoSeven® During "Real-life" Usage in Germany N/A
Completed NCT00914589 - Multi-national Study Investigating the Effect and Safety of rFXIII on Transfusion Needs in Patients Undergoing Heart Surgery Phase 2
Completed NCT00102037 - Use of Activated Recombinant FVII in Spinal Surgery Phase 2
Completed NCT01562821 - Safety and Efficacy of Activated Recombinant Human Factor VII in Cirrhotic Patients Undergoing Partial Hepatectomy Phase 2
Completed NCT01601613 - Activated Recombinant Human Factor VII in Patients With Dengue Haemorrhagic Fever Phase 2
Completed NCT00123591 - Safety and Preliminary Efficacy of Recombinant Activated Factor VII in Subjects With Traumatic Brain Injury Phase 2
Completed NCT01562574 - Activated Recombinant Human Factor VII Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease Phase 3
Completed NCT01285089 - Observational Study on the Use of NovoSeven® for Haemostatic Treatment of Bleeding Episodes in Patients With Acquired Haemophilia N/A
Terminated NCT00154427 - Use of Activated Recombinant Human Factor VII in Cardiac Surgery Phase 2
Completed NCT00426803 - Recombinant Factor VIIa in Acute Intracerebral Haemorrhage Phase 2

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