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
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
...
Informed consent obtained before any study-related activities. Study-related activities are any procedure related to recording of data according to the protocol
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
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%)

Exclusion Criteria

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)
...
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)
Treatment with any investigational drug within 30 days prior to enrolment into the study

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
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
...
Informed consent obtained before any study-related activities. Study-related activities are any procedure related to recording of data according to the protocol
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
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%)

Exclusion Criteria

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)
...
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)
Treatment with any investigational drug within 30 days prior to enrolment into the study

Tracking Information

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