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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
  Purpose
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 Intervention
Congenital Bleeding Disorder Haemophilia A Haemophilia B Drug: activated recombinant human factor VII

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: United Kingdom Haemophilia Centre Doctor's Organisation (UKHCDO) - Novo Nordisk Collaboration on NovoSeven® Post Marketing Follow-up Measures

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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 ]

Enrollment: 139
Study Start Date: January 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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 Submitted: February 27, 2009
First Posted: March 2, 2009
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