Observational Study on Safety of Room Temperature Stable NovoSeven® in Patients With Haemophilia A or B

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

NCT01220141

NN7025-3601

U1111-1116-2012 (Other Identifier)

Details and patient eligibility

About

This study is conducted in Europe and Asia. The aim of this observational study is to monitor antibody formation towards the room temperature stable formulation of NovoSeven® (activated recombinant human factor VII).

Enrollment: 51 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Diagnosed with congenital haemophilia A or B with inhibitors to factor VIII or factor IX
• Treated with room temperature stable NovoSeven®

Trial design

51 participants in 1 patient group

A

Treatment:

Drug: activated recombinant human factor VII