Brief Title
Post-marketing Safety Surveillance of NovoSeven® in Patients With Haemophilia and Inhibitors by Means of the UK Haemophilia Database
Official Title
United Kingdom Haemophilia Centre Doctor's Organisation (UKHCDO) - Novo Nordisk Collaboration on NovoSeven® Post Marketing Follow-up Measures
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.
Study Type
Observational
Primary Outcome
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.
Condition
Congenital Bleeding Disorder
Intervention
activated recombinant human factor VII
Study Arms / Comparison Groups
A
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
139
Start Date
January 2008
Completion Date
June 2011
Primary Completion Date
June 2011
Eligibility Criteria
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
Gender
Male
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Global Clinical Registry (GCR, 1452), ,
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT00853086
Organization ID
F7HAEM-3537
Secondary IDs
U1111-1130-5940
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S
Verification Date
November 2016