Status:

COMPLETED

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

Lead Sponsor:

Novo Nordisk A/S

Conditions:

Congenital Bleeding Disorder

Haemophilia A

Eligibility:

MALE

Brief Summary

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.

Detailed Description

Non-interventional, retrospective data collection on standard treatments of haemophilia A and B patients with inhibitors in the UK.

Eligibility Criteria

Inclusion

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

Exclusion

  • No exclusion criteria beyond the contraindications described in the approved product information text

Key Trial Info

Start Date :

January 1 2008

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

June 1 2011

Estimated Enrollment :

139 Patients enrolled

Trial Details

Trial ID

NCT00853086

Start Date

January 1 2008

End Date

June 1 2011

Last Update

November 16 2016

Active Locations (1)

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1

Novo Nordisk Investigational Site

Crawley, United Kingdom, RH11 9RT