Non-Interventional Study of NovoSeven® Used in Patients With Haemophilia A and B With Inhibitors Under Normal Clinical Practice

Completed

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

• Registration Number: NCT01579955
• 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®) 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: 2017-02-22
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 321

Inclusion Criteria

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

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
Percentage of bleed treatments resulting in effective bleed resolution: Markedly effective, effective, moderate or ineffective	Year 10

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇯🇵 Tokyo, Japan