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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Congenital Bleeding Disorder Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Haemophilia A Haemophilia B Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemophilia B Hemorrhagic Disorders

Sex eligibility

Male

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Crawley, RH11 9RT, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

activated recombinant human factor VII

Drug

Safety data collection in connection with the use of the drug NovoSeven® in daily clinical practice

Other names: NovoSeven®, rFVIIa, F7

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

United Kingdom Haemophilia Centre Doctor's Organisation (UKHCDO) - Novo Nordisk Collaboration on NovoSeven® Post Marketing Follow-up Measures

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Mar 2, 2009
Registry last updated: Nov 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed