Status:
COMPLETED
Observational Patient Diary Study of Treatment Doses for Patients With Haemophilia With Inhibitors to Factors VIII and IX
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Congenital Bleeding Disorder
Haemophilia A With Inhibitors
Eligibility:
MALE
Brief 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 wit...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00710619
Start Date
June 1 2008
End Date
July 1 2009
Last Update
November 17 2016
Active Locations (1)
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1
Novo Nordisk Investigational Site
Plainsboro, New Jersey, United States, 08536