Observational Patient Diary Study of Treatment Doses for Patients With Haemophilia With Inhibitors to Factors VIII and IX (DOSE)

Novo Nordisk

Status: Completed

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

Treatments: Drug: activated recombinant human factor VII; Drug: Feiba VH

Study type: Observational

Funder types: Industry

Identifiers

NCT00710619

F7HAEM-1965

Details and patient eligibility

About

This study is conducted in the United States of America (USA). The aim of this study is to investigate the at-home-administration of bypassing agents for treatment of bleeding episodes in patients with congenital haemophilia with inhibitors to factors VIII and IX. We are further investigating how bleeding episodes affect the quality of life of the patient and their family or caregivers.

Enrollment: 52 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Male subjects with congenital haemophilia A or B and inhibitors with spontaneous bleeds which require on-demand treatment
• Subjects prescribed NovoSeven® as the first line or recommended bypass agent
• History of on average at least 4 bleeds of any type over a 3 month period
• Subject or caregiver able and willing to complete daily journal for 3 months
• Informed consent obtained from all subjects or legal representative

Trial design

52 participants in 1 patient group

A

Treatment:

Drug: activated recombinant human factor VII

Drug: Feiba VH