Recruitment

Recruitment Status
Completed
Estimated Enrollment
70

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
...
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

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

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 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
...
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

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

Locations

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

Tracking Information

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