Recruitment

Recruitment Status
Completed
Estimated Enrollment
70

Inclusion Criterias

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%)
A negative FVIII inhibitor test obtained not more than four weeks prior to first dosing with turoctocog alfa
...
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%)
A negative FVIII inhibitor test obtained not more than four weeks prior to first dosing with turoctocog alfa
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

Exclusion Criterias

Treatment with any investigational drug within 30 days prior to enrolment into the study
Treatment with other FVIII products after initiation of treatment with turoctocog alfa
Previous participation in any clinical trial with turoctocog alfa
...
Treatment with any investigational drug within 30 days prior to enrolment into the study
Treatment with other FVIII products after initiation of treatment with turoctocog alfa
Previous participation in any clinical trial with turoctocog alfa
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)

Summary

Conditions
  • Congenital Bleeding Disorder
  • Haemophilia A
Type
Observational
Design
  • Observational Model: Cohort
  • Time Perspective: Prospective

Participation Requirements

Age
Younger than 125 years
Gender
Only males

Inclusion Criterias

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%)
A negative FVIII inhibitor test obtained not more than four weeks prior to first dosing with turoctocog alfa
...
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%)
A negative FVIII inhibitor test obtained not more than four weeks prior to first dosing with turoctocog alfa
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

Exclusion Criterias

Treatment with any investigational drug within 30 days prior to enrolment into the study
Treatment with other FVIII products after initiation of treatment with turoctocog alfa
Previous participation in any clinical trial with turoctocog alfa
...
Treatment with any investigational drug within 30 days prior to enrolment into the study
Treatment with other FVIII products after initiation of treatment with turoctocog alfa
Previous participation in any clinical trial with turoctocog alfa
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)

Locations

Münster, 48143
Utrecht, 3584 CX
Bordeaux, 33076
Braunschweig, 38118
Palermo, 90127
...
Münster, 48143
Utrecht, 3584 CX
Bordeaux, 33076
Braunschweig, 38118
Palermo, 90127
Mobile, Alabama, 36604
Castelfranco Veneto, 31033
Kosice, 04001
Graz, 8036
Strasbourg, 67098
Malmö, 205 02
Albuquerque, New Mexico, 87106
Ljubljana, 1000
Montmorency, 95160
Torrance, California, 90502-2004
Frankfurt / Main, 60596
Leipzig, 04289
Debrecen, 4032
Mohács, 7700
Banska Bystrica, 975 17
Linz, 4020
Mörfelden-Walldorf, 64546
Stockholm, 171 76
Brno, 625 00
Saint Etienne, 42055
Duisburg, 47051
Barcelona, 08035
Peoria, Illinois, 61615
Zürich, 8091
Salt Lake City, Utah, 84113
Den Haag, 2545AA
Budapest, H-1134
Giessen, 35392
Firenze, 50134
Charlotte, North Carolina, 28203
Warszawa, 02-091
Athens, GR-11527
Catania, 95123
Rennes, 35033
Padova, 35128
München, 80331

Tracking Information

NCT #
NCT02035384
Collaborators
Not Provided
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S