Safety and Efficacy of Turoctocog Alfa During Long-Term Treatment of Severe and Moderately Severe Haemophilia A
Last updated on April 2022Recruitment
- 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
- 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%)
- ...
- 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
- 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
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)
- Previous participation in any clinical trial with turoctocog alfa
- Treatment with other FVIII products after initiation of treatment 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)
- Previous participation in any clinical trial with turoctocog alfa
- Treatment with other FVIII products after initiation of treatment with turoctocog alfa
- 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
- 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%)
- ...
- 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
- 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
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)
- Previous participation in any clinical trial with turoctocog alfa
- Treatment with other FVIII products after initiation of treatment 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)
- Previous participation in any clinical trial with turoctocog alfa
- Treatment with other FVIII products after initiation of treatment with turoctocog alfa
- 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
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