Safety and Efficacy of Turoctocog Alfa During Long-Term Treatment of Severe and Moderately Severe Haemophilia A (guardian™ 5)

Novo Nordisk

Status: Completed

Conditions: Haemophilia A; Congenital Bleeding Disorder

Treatments: Drug: turoctocog alfa

Study type: Observational

Funder types: Industry

Identifiers

NCT02035384

ENCEPP/SDPP/5501 (Registry Identifier)

U1111-1126-0353 (Other Identifier)

NN7008-3553

Details and patient eligibility

About

This study is conducted in Europe, and North and South America. The aim of this study is to provide additional documentation of the immunogenicity, and obtain additional clinical data, of turoctocog alfa in the setting of normal clinical practise in patients previously treated with a factor VIII agent (FVIII).

Enrollment: 69 patients

Sex: Male

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
• Previously FVIII treated (150 exposure days at the time of first dosing with turoctocog alfa) male patients with the diagnosis of severe and moderately severe haemophilia A (FVIII below or equal to 2%)
• The decision to initiate treatment with commercially available turoctocog alfa has been made by the patient/parent and the patient's treating physician before and independently from the decision to include the patient in this study
• A negative FVIII inhibitor test obtained not more than four weeks prior to first dosing with turoctocog alfa

Exclusion criteria

• Contraindications for use according to the approved product information text (US Package insert (PI), European Summary of Product Characteristics (SmPC), or corresponding local prescribing information)
• Treatment with any investigational drug within 30 days prior to enrolment into the study
• Previous participation in any clinical trial with turoctocog alfa
• Treatment with other FVIII products after initiation of treatment with turoctocog alfa

Trial design

69 participants in 1 patient group

All patients

Treatment:

Drug: turoctocog alfa