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

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Anti-inhibitor coagulant complex

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