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

Completed

Conditions studied: Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors

In brief

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.

Key facts

Study ID

NCT00710619

Run by

Novo Nordisk A/S

People needed

52

Starts

2008-06-01

Expected to finish

2009-07-01

Last updated by the study team

2016-11-17

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Plainsboro, New Jersey, United States

Full record on ClinicalTrials.gov

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