Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A (guardian™4)

Novo Nordisk

Status and phase

Completed

Phase 3

Conditions

Haemophilia A

Congenital Bleeding Disorder

Treatments

Drug: turoctocog alfa

Study type

Interventional

Funder types

Industry

Identifiers

NCT01493778

NN7008-3809

U1111-1119-6116 (Other Identifier)

P/50/2010 (Other Identifier)

JapicCTI-142544 (Other Identifier)

2011-001033-16 (EudraCT Number)

CTR20150455 (Registry Identifier)

Details and patient eligibility

About

This trial is conducted in Asia, Europe and North America. The purpose of the trial is to evaluate the safety and efficacy of turoctocog alfa in prevention and treatment of bleeds in previously untreated children with haemophilia A.

Enrollment

60 patients

Sex

Male

Ages

Under 6 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age below 6 years
Informed consent obtained before any trial-related activities (trial-related activities are any procedure that would not have been performed during normal management of the patient)
Male patients diagnosed with congenital severe haemophilia A (FVIII level equal to or below 1%)
No prior use of purified clotting factor products (previous exposure, equal to or less than 5 ED to blood components, e.g. cryoprecipitate, fresh frozen plasma, is accepted) including commercially available NovoEight® /Novoeight®

Exclusion criteria

Known or suspected allergy to hamster protein or intolerance to trial product(s) or related products
Previous participation in this trial defined as withdrawal after administration of trial product
Congenital or acquired coagulation disorders other than haemophilia A
Any history of Factor VIII inhibitor
Ongoing treatment or planned treatment during the trial with immunomodulatory agents (e.g. intravenous immunoglobulin (IVIG), routine systemic corticosteroids)