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Post-marketing Safety Surveillance of NovoSeven® in Patients With Haemophilia and Inhibitors by Means of the UK Haemophilia Database

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00853086
First received: February 27, 2009
Last updated: June 15, 2012
Last verified: June 2012
History of Changes

February 27, 2009
June 15, 2012
January 2008
June 2011   (final data collection date for primary outcome measure)
Quantify number of thrombotic events in patients treated with the currently recommended dose of 90 microgram/kg compared with higher rFVIIa dose levels up to 270 microgram/kg in relation to number of treatment episodes. [ Time Frame: Assessments at 6 month intervals ] [ Designated as safety issue: Yes ]
Quantify number of thrombotic events in patients treated with the currently recommended dose of 90 microgram/kg compared with higher rFVIIa dose levels up to 270 microgram/kg in relation to number of treatment episodes [ Time Frame: Assessments at 6 month intervals ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00853086 on ClinicalTrials.gov Archive Site
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Post-marketing Safety Surveillance of NovoSeven® in Patients With Haemophilia and Inhibitors by Means of the UK Haemophilia Database
United Kingdom Haemophilia Centre Doctor's Organisation (UKHCDO) - Novo Nordisk Collaboration on NovoSeven® Post Marketing Follow-up Measures

This study is conducted in Europe. The purpose of this retrospective study is to collect additional safety information of patients with haemophilia and inhibitors who are treated with rFVIIa.

Non-interventional, retrospective data collection on standard treatments of haemophilia A and B patients with inhibitors in the UK.
Observational
Observational Model: Cohort
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Not Provided
Non-Probability Sample

Patients from speciality practice settings
  • Congenital Bleeding Disorder
  • Haemophilia A
  • Haemophilia B
Drug: activated recombinant human factor VII
Safety data collection in connection with the use of the drug NovoSeven® in daily clinical practice
Other Names:
  • NovoSeven®
  • rFVIIa
  • F7
A
Intervention: Drug: activated recombinant human factor VII
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
194
June 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All haemophilia A or B patients with inhibitors treated with NovoSeven are included

Exclusion Criteria:

  • No exclusion criteria beyond the contraindications described in the approved product information text
Male
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No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00853086
F7HAEM-3537, U1111-1130-5940
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk
Not Provided
Study Director: Nicola Maria Wennerwald, MA Novo Nordisk
Novo Nordisk
June 2012

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