Brief Title
Investigation of the Pharmacokinetics of Turoctocog Alfa in Subjects With Haemophilia A
Official Title
Multi-centre, Open-labelled Trial Investigating the Pharmacokinetics of Four Lots of Turoctocog Alfa in Subjects With Haemophilia A
Brief Summary
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) of four lots of turoctocog alfa (a human recombinant coagulation factor VIII (FVIII)) in subjects with haemophilia A.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Dose normalised area under the curve (AUC/actual dose) based on chromogenic assay
Secondary Outcome
Dose normalised area under the FVIII activity-time curve (AUC/actual dose) based on one stage clot assay
Condition
Congenital Bleeding Disorder
Intervention
turoctocog alfa
Study Arms / Comparison Groups
Lot A
Description: Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days.
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
15
Start Date
December 2012
Completion Date
March 2013
Primary Completion Date
March 2013
Eligibility Criteria
Inclusion Criteria: - Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - Male subjects with the diagnosis of severe haemophilia A (FVIII<1%) from age 18 years - Documented history of at least 150 exposure days to any other FVIII products (prevention or treatment of bleeds) - Immunocompetent (HIV (Human Immunodeficiency Virus) positive subjects should have CD4+ (Cluster of differentiation 4; a glycoprotein expressed on the surface) lymphocyte count >200/microL) Exclusion Criteria: - Detectable inhibitors to FVIII (above or equal to 0.6 Bethesda Units (BU)) - History of FVIII inhibitors - Severe current hepatic dysfunction or severe hepatic disease during the last 12 months - Known or suspected allergy to trial product (FVIII) or related products - Subjects receiving immune modulating medication or immune tolerance induction (ITI) regimens - Body mass index (BMI) above 30 kg/m^2
Gender
Male
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Global Clinical Registry (GCR, 1452), ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT01692925
Organization ID
NN7008-4015
Secondary IDs
2012-001444-21
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S
Verification Date
February 2017