Brief Title
Safety and Efficacy of Turoctocog Alfa During Long-Term Treatment of Severe and Moderately Severe Haemophilia A
Official Title
A Multi-centre Non-interventional Study of Safety and Efficacy of Turoctocog Alfa (rFVIII) During Long-Term Treatment of Severe and Moderately Severe Haemophilia A (FVIII =<2%)
Brief Summary
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).
Study Type
Observational
Primary Outcome
Incidence rate of FVIII inhibitors (at least 0.6 Bethesda Units (BU) for central laboratory analyses, or above the specific local laboratory reference range) represented as the percentage of patients developing inhibitors
Secondary Outcome
Number of adverse reactions reported
Condition
Congenital Bleeding Disorder
Intervention
turoctocog alfa
Study Arms / Comparison Groups
All patients
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
69
Start Date
June 5, 2014
Completion Date
January 15, 2020
Primary Completion Date
January 15, 2020
Eligibility Criteria
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
Gender
Male
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Global Clinical Registry (GCR, 1452), ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT02035384
Organization ID
NN7008-3553
Secondary IDs
U1111-1126-0353
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S
Verification Date
April 2020