Non-Interventional Study of NovoSeven® Used as On-demand Treatment of Bleeds in Patients With Haemophilia A and B With Inhibitors

Completed

• Conditions: Haemophilia B With Inhibitors; Haemophilia A With Inhibitors; Congenital Bleeding Disorder
• Interventions: Drug: eptacog alfa (activated)

• Registration Number: NCT01586936
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Japan. The aim of this registry study is to observe the use of single dose and multi-dose use of eptacog alpha (NovoSeven®) and to compare short-term outcomes, including effectiveness, safety, quality of life and treatment satisfaction with the approved treatments.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-03-10
• Primary Completion: 2010-03-09
• Study Completion: 2010-03-09
• Study First Submitted: 2012-04-11
• Study First Submitted QC: 2012-04-25
• Study First Posted: 2012-04-27
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Treated with eptacog alpha (NovoSeven®)

Exclusion Criteria

• Investigator decision to measure for antibody as unnecessary medical testing

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
eptacog alpha users	eptacog alfa (activated)	-

Primary Outcome Measures

Name	Time	Method
Antibody production against eptacog alpha	Up to 10 years

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇯🇵 Tokyo, Japan