Brief Title
Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A
Official Title
A Multicentre, Open-label Trial Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A
Brief Summary
This trial is conducted globally. The aim of this trial is evaluating the pharmacokinetics (the exposure of the trial drug in the body) of NovoEight® (turoctocog alfa) in relation to BMI (body mass index) in subjects with haemophilia A.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Plasma FVIII activity at 30 minutes(C30min)
Secondary Outcome
Area under the FVIII activity-time curve
Condition
Congenital Bleeding Disorder
Intervention
turoctocog alfa
Study Arms / Comparison Groups
Turoctocog alfa
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
35
Start Date
October 10, 2016
Completion Date
June 20, 2017
Primary Completion Date
June 20, 2017
Eligibility Criteria
Inclusion Criteria: - Male, age at least 18 years at the time of signing informed consent - History of more than 150 exposure days to any factor VIII products - Subjects with the diagnosis of congenital haemophilia A with factor VIII activity below 1%, based on medical records Exclusion Criteria: - Known history of factor VIII inhibitors - Inhibitors to factor VIII (above or equal to 0.6 BU (Bethesda units)) at screening measured by the Nijmegen modified Bethesda method - Known congenital or acquired coagulation disorders other than haemophilia A - Previous participation in pharmacokinetic sessions with turoctocog alfa in another trial
Gender
Male
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT02941354
Organization ID
NN7008-4239
Secondary IDs
2015-004379-56
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
, ,
Verification Date
January 2019