Clinical trial NCT01692925: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Congenital Bleeding Disorder
Haemophilia A
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-09-26
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Dose normalised area under the curve (AUC/actual dose) based on chromogenic assay
timeFrame: up to 48 hours after i.v. administration
Secondary outcomes:
measure: Dose normalised area under the FVIII activity-time curve (AUC/actual dose) based on one stage clot assay
timeFrame: up to 48 hours after i.v. administration
measure: Incremental recovery (IR30min) (defined as the peak FVIII level recorded 30 min after injection and reported as[IU/mL]/[IU/kg])
timeFrame: up to 48 hours after i.v. administration
measure: Area under the FVIII activity-time curve (AUC)
timeFrame: up to 48 hours after i.v. administration
measure: Terminal half-life of FVIII (t½)
timeFrame: up to 48 hours after i.v. administration
measure: Clearance of FVIII (CL)
timeFrame: up to 48 hours after i.v. administration
measure: Incidence of adverse events (AEs) including FVIII inhibitors
timeFrame: After approximately 3 months (at end of trial)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Frankfurt/M.
country: Germany
facility: Novo Nordisk Investigational Site
city: Riga
country: Latvia
facility: Novo Nordisk Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Jimenez-Yuste V, Lejniece S, Klamroth R, Suzuki T, Santagostino E, Karim FA, Saugstrup T, Moss J. The pharmacokinetics of a B-domain truncated recombinant factor VIII, turoctocog alfa (NovoEight(R)), in patients with hemophilia A. J Thromb Haemost. 2015 Mar;13(3):370-9. doi: 10.1111/jth.12816. Epub 2015 Feb 13.