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

Novo Nordisk

Status: Completed

Conditions: Haemophilia B; Haemophilia A; Congenital Bleeding Disorder

Treatments: Drug: activated recombinant human factor VII

Study type: Observational

Funder types: Industry

Identifiers

NCT00853086

F7HAEM-3537

U1111-1130-5940 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 139 patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

139 participants in 1 patient group

A

Treatment:

Drug: activated recombinant human factor VII