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

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ClinicalTrials.gov Identifier: NCT00853086
Recruitment Status : Completed
First Posted : March 2, 2009
Last Update Posted : November 16, 2016
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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.

Condition or disease Intervention/treatment
Congenital Bleeding Disorder Haemophilia A Haemophilia B Drug: activated recombinant human factor VII

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

Study Type : Observational
Actual Enrollment : 139 participants
Observational Model: Cohort
Official Title: United Kingdom Haemophilia Centre Doctor's Organisation (UKHCDO) - Novo Nordisk Collaboration on NovoSeven® Post Marketing Follow-up Measures
Study Start Date : January 2008
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
A 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



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients from speciality practice settings
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00853086


Locations
United Kingdom
Novo Nordisk Investigational Site
Crawley, United Kingdom, RH11 9RT
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00853086     History of Changes
Other Study ID Numbers: F7HAEM-3537
U1111-1130-5940 ( Other Identifier: WHO )
First Posted: March 2, 2009    Key Record Dates
Last Update Posted: November 16, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Hemophilia A
Hemophilia B
Blood Coagulation Disorders
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Vascular Diseases
Cardiovascular Diseases