Non-Interventional Study of NovoSeven® Used in Patients With Haemophilia A and B With Inhibitors When Undergoing Surgery

Completed

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

• Registration Number: NCT01579968
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Japan. The aim of this non-interventional study is to investigate the safety and effectiveness of treatment with eptacog alpha (NovoSeven®) when undergoing surgery under normal clinical practice conditions.

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: 2012-04-17
• Study First Posted: 2012-04-18
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• Patients with haemophilia A and B with inhibitors who received eptacog alpha (NovoSeven®) as treatment when undergoing surgery

Exclusion Criteria

• Patients who was not deemed to be appropriate to the treatment of eptacog alpha (NovoSeven®)

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
Physician's assessment of the evaluation for efficacy: Amount of blood at surgery, condition of haemostasis after surgery or maintenance of cessation of bleed	Year 10

Secondary Outcome Measures

Name	Time	Method
Number of adverse events (AEs), including serious adverse events (SAEs)	Year 1, Year 10

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇯🇵 Tokyo, Japan