Observational Study Describing the Usual Clinical Practice Use of NovoSeven® in the Home Treatment of Joint Bleeds in Patients With Haemophilia A or B and Inhibitors

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

NCT01234545

F7HAEM-3850

U1111-1116-2488 (Other Identifier)

Details and patient eligibility

About

This trial is conducted in Africa and Asia. The aim of this study is to evaluate the efficacy of home treatment of joint bleeds (haemarthrosis) with NovoSeven® (activated recombinant human factor VII) in patients with haemophilia A and B patients with inhibitors.

Enrollment: 35 patients

Sex: Male

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with congenital haemophilia and inhibitors to factor VIII or IX
• Indication of activated recombinant human factor VII for the treatment of joint bleeding located in elbow, shoulder, wrist, hip, knee, ankle

Exclusion criteria

• Known or suspected allergy to study product(s) or related products
• Clinically relevant coagulation disorders other than congenital haemophilia A or B

Trial design

35 participants in 1 patient group

A

Treatment:

Drug: activated recombinant human factor VII