Text Size

Non-Interventional Study of NovoSeven® Used in Patients With Haemophilia A and B With Inhibitors When Undergoing Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01579968
First received: April 11, 2012
Last updated: March 5, 2013
Last verified: February 2013
History of Changes

April 11, 2012
March 5, 2013
March 1999
March 2010   (final data collection date for primary outcome measure)
  • Physician's assessment of the evaluation for efficacy: Amount of blood at surgery, condition of haemostasis after surgery or maintenance of cessation of bleed [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
  • Physician's assessment of the evaluation for efficacy: Amount of blood at surgery, condition of haemostasis after surgery or maintenance of cessation of bleed [ Time Frame: Year 10 ] [ Designated as safety issue: No ]
  • Physician's assessment of the evaluation for efficacy: Amount of blood at surgery, condition of haemostasis after surgery or maintainance of cessasion of bleed [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
  • Physician's assessment of the evaluation for efficacy: Amount of blood at surgery, condition of haemostasis after surgery or maintainance of cessasion of bleed [ Time Frame: Year 10 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01579968 on ClinicalTrials.gov Archive Site
Number of adverse events (AEs), including serious adverse events (SAEs) [ Time Frame: Year 1, Year 10 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Non-Interventional Study of NovoSeven® Used in Patients With Haemophilia A and B With Inhibitors When Undergoing Surgery
Non-Interventional Study of NovoSeven® Used in Patients With Haemophilia A and B With Inhibitors When Undergoing Surgery

This study is conducted in Japan. The aim of this non-interventional study is to investigate the safety and effectiveness of treatment with eptacog alpha (NovoSeven®) when undergoing surgery under normal clinical practice conditions.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with haemophilia A and B with inhibitors who received NovoSeven® (eptacog alpha) as treatment when undergoing the surgery
  • Congenital Bleeding Disorder
  • Haemophilia A With Inhibitors
  • Haemophilia B With Inhibitors
Drug: eptacog alfa (activated)
Safety and effectiveness data collection in connection with the use of eptacog alpha in daily clinical practice
eptacog alpha users
Intervention: Drug: eptacog alfa (activated)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
March 2010
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with haemophilia A and B with inhibitors who received eptacog alpha (NovoSeven®) as treatment when undergoing surgery

Exclusion Criteria:

  • Patients who was not deemed to be appropriate to the treatment of eptacog alpha (NovoSeven®)
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01579968
F7-1948
No
Novo Nordisk
Novo Nordisk
Not Provided
Study Director: Hiroshi Tsuchiya Novo Nordisk Pharma Ltd.
Novo Nordisk
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP