Status:

COMPLETED

To Investigate Safety and Efficacy of NovoEight® (rFVIII) During Long-term Treatment of Haemophilia A in Japan

Lead Sponsor:

Novo Nordisk A/S

Conditions:

Congenital Bleeding Disorder

Haemophilia A

Eligibility:

All Genders

Brief Summary

This study is conducted in Asia. The aim of this study is to evaluate the safety and efficacy of NovoEight® (recombinant factor VIII) in patients with haemophilia A in Japan in the setting of routine ...

Eligibility Criteria

Inclusion

  • Informed consent obtained before any study-related activities. Study-related activities are any procedure related to recording of data according to the protocol
  • Male and female patients with the diagnosis of haemophilia A
  • Age range is 0 year and above
  • A decision to initiate treatment with commercially available NovoEight® has been made by the patient/parent and the physician

Exclusion

  • Known or suspected allergy to study product(s) or related products
  • Previous participation in this study. Participation is defined as informed consent obtained
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

Key Trial Info

Start Date :

August 4 2014

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

November 10 2020

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT02207218

Start Date

August 4 2014

End Date

November 10 2020

Last Update

November 15 2021

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Novo Nordisk Investigational Site

Suginami-ku, Tokyo, Japan, 1670035

2

Novo Nordisk Investigational Site

Tokyo, Japan, 167-0035

To Investigate Safety and Efficacy of NovoEight® (rFVIII) During Long-term Treatment of Haemophilia A in Japan | DecenTrialz