Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A (pathfinder™6)

Novo Nordisk

Status and phase

Completed

Phase 3

Conditions

Haemophilia A

Congenital Bleeding Disorder

Treatments

Drug: turoctocog alfa pegol

Study type

Interventional

Funder types

Industry

Identifiers

NCT02137850

U1111-1148-1897 (Other Identifier)

NN7088-3908

2013-004025-88 (EudraCT Number)

JapicCTI-142577 (Other Identifier)

REec-2014-0898 (Registry Identifier)

Details and patient eligibility

About

This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of turoctocog alfa pegol (N8-GP) in previously untreated patients (PUPs) with haemophilia A.

Enrollment

124 patients

Sex

Male

Ages

Under 6 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
Male, age below 6 years of age at the time of signing informed consent
Diagnosis of severe haemophilia A (FVIII activity level 1%) based on medical records or central laboratory results
No prior use of purified clotting factor products (5 previous exposures to blood components is acceptable)

Exclusion criteria

Any history of FVIII inhibitor (defined by medical records) - Known or suspected hypersensitivity to trial product or related products
Previous participation in this trial. Participation is defined as first dose administered of trial product
Receipt of any investigational medicinal product within 30 days before screening
Congenital or acquired coagulation disorder other than haemophilia A
Any chronic disorder or severe disease which, in the opinion of the Investigator, might jeopardise the patient's safety or compliance with the protocol
Patient's parent(s')/legally acceptable representative (LAR(s')) mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation