Non-Interventional Study of NovoSeven® Used as On-demand Treatment of Bleeds in Patients With Haemophilia A and B With Inhibitors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01586936
First received: April 11, 2012
Last updated: March 5, 2013
Last verified: February 2013

April 11, 2012
March 5, 2013
March 1999
March 2010   (final data collection date for primary outcome measure)
Antibody production against eptacog alpha [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01586936 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Non-Interventional Study of NovoSeven® Used as On-demand Treatment of Bleeds in Patients With Haemophilia A and B With Inhibitors
Special Survey of Production of Antibody Against Coagulation

This study is conducted in Japan. The aim of this registry study is to observe the use of single dose and multi-dose use of eptacog alpha (NovoSeven®) and to compare short-term outcomes, including effectiveness, safety, quality of life and treatment satisfaction with the approved treatments.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Retention:   Samples Without DNA
Description:

Serum

Non-Probability Sample

Patients from general practice setting who have been deemed appropriate to receive NovoSeven® (eptacog alpha) as new treatment and as part of routine out-patient care by the prescribing physician

  • Congenital Bleeding Disorder
  • Haemophilia A With Inhibitors
  • Haemophilia B With Inhibitors
Drug: eptacog alfa (activated)
Prescription of eptacog alpha at the discretion of the physician
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
8
March 2010
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Treated with eptacog alpha (NovoSeven®)

Exclusion Criteria:

  • Investigator decision to measure for antibody as unnecessary medical testing
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01586936
F7-1949
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Hiroshi Tsuchiya Novo Nordisk Pharma Ltd.
Novo Nordisk A/S
February 2013

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