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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:
ClinicalTrials.gov Identifier:
NCT00853086
First Posted: March 2, 2009
Last Update Posted: November 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
February 27, 2009
March 2, 2009
November 16, 2016
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 ]
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 ]
Complete list of historical versions of study NCT00853086 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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
Not Provided
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
139
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
Sexes Eligible for Study: Male
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00853086
F7HAEM-3537
U1111-1130-5940 ( Other Identifier: WHO )
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
November 2016