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

Novo Nordisk

Status: Completed

Conditions: Haemophilia A; Congenital Bleeding Disorder

Treatments: Drug: turoctocog alfa

Study type: Observational

Funder types: Industry

Identifiers

NCT02207218

U1111-1144-8212 (Other Identifier)

NN7008-4105

Details and patient eligibility

About

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 clinical practice.

Enrollment: 40 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

40 participants in 1 patient group

NovoEight®

Treatment:

Drug: turoctocog alfa