Observational Registry of NovoSeven® Used as On-demand Treatment of Bleeds in Patients With Haemophilia A and B With Inhibitors (ONE)

Novo Nordisk

Status: Completed

Conditions: Haemophilia B With Inhibitors; Haemophilia A With Inhibitors; Congenital Bleeding Disorder

Treatments: Drug: eptacog alfa (activated)

Study type: Observational

Funder types: Industry

Identifiers

NCT00703911

F7HAEM-3507

Details and patient eligibility

About

This study was conducted in Africa, Europe, the Middle-East and South America. The primary objective of this registry was to observe the use of single dose and multi-dose use of activated recombinant human factor VII and to compare short-term outcomes, including effectiveness, safety, quality of life and treatment satisfaction with the approved treatments.

Enrollment: 102 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with haemophilia A or B with inhibitors
• Experience mild to moderate spontaneous bleeds which require on-demand treatment and who are currently prescribed activated recombinant human factor VII
• Be able and willing to provide informed consent (or proxy consent by caregiver, if applicable), as required by local research ethics committee, governmental or regulatory authorities
• Be willing to provide information on at least one alternate contact person in the event that the patient be somehow lost-to-follow-up over the course of registry participation (not applicable if patient is withdrawn)

Exclusion criteria

• Known hypersensitivity to the active substance or the excipients in the formulation of activated recombinant human factor VII, or to mouse, hamster or bovine protein

Trial design

102 participants in 1 patient group

activated recombinant human factor VII

Description:

Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds

Treatment:

Drug: eptacog alfa (activated)