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:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00853086
First received: February 27, 2009
Last updated: June 15, 2012
Last verified: June 2012
  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 ] [ Designated as safety issue: Yes ]

Enrollment: 194
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

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00853086

Locations
United Kingdom
Crawley, United Kingdom, RH11 9RT
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Nicola Maria Wennerwald, MA Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00853086     History of Changes
Other Study ID Numbers: F7HAEM-3537, U1111-1130-5940
Study First Received: February 27, 2009
Last Updated: June 15, 2012
Health Authority: United Kingdom: Not required for observational study

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

ClinicalTrials.gov processed this record on July 20, 2014