Clinical trial NCT02941354: 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
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: 2016-10-21
Enrollment: 35
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Plasma FVIII activity at 30 minutes(C30min)
timeFrame: At 30 minutes post-dose
Secondary outcomes:
measure: Area under the FVIII activity-time curve
timeFrame: From 0 up to 72 hours after administration
measure: Incremental recovery FVIII at 30 minutes (IR30min)
timeFrame: At 30 minutes post-dose
measure: Terminal half-life (t½) of FVIII
timeFrame: From 0 up to 72 hours after administration
measure: Clearance (CL) of FVIII
timeFrame: From 0 up to 72 hours after administration
measure: Apparent volume of distribution at steady state (Vss) of FVIII
timeFrame: From 0 up to 72 hours after administration
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Peoria
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Memphis
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Richmond
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Wien
country: Austria
facility: Novo Nordisk Investigational Site
city: Sofia
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Bonn
country: Germany
facility: Novo Nordisk Investigational Site
city: Hannover
country: Germany
facility: Novo Nordisk Investigational Site
city: Belgrade
country: Serbia
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Málaga
country: Spain
facility: Novo Nordisk Investigational Site
city: Valencia
country: Spain
facility: Novo Nordisk Investigational Site
city: Vigo
country: Spain
facility: Novo Nordisk Investigational Site
city: Changhua
country: Taiwan
facility: Novo Nordisk Investigational Site
city: Taipei
country: Taiwan
facility: Novo Nordisk Investigational Site
Study officials:
References: