Clinical trial NCT02920398: A Multi-centre, Comparative, Double Blind, Randomised Cross-over Trial Investigating Single Dose Pharmacokinetics and Safety of Turoctocog Alfa Pegol From the Pivotal Process and Turoctocog Alfa Pegol From the Commercial Process in Patients With Severe Haemophilia A
Official title: This Trial is Conducted in Europe and the United States of America. The Aim of This Trial is to Investigate Single Dose Pharmacokinetics (the Exposure of the Trial Drug in the Body) and Safety of Turoctocog Alfa Pegol From the Pivotal Process and Turoctocog Alfa Pegol From the Commercial Process in Patients With Severe 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: 2016-09-30
Enrollment: 21
Sex: MALE
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Investigating single dose pharmacokinetics and safety of turoctocog alfa pegol from the pivotal process and turoctocog alfa pegol from the commercial process in patients with severe 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
* Ongoing participation in pathfinder™2
* Male, age at least 12 years at the time of signing informed consent (in certain countries the lower age limit will be 18 years, according to local requirements)

Exclusion Criteria:

* FVIII inhibitors (≥0.6 BU) at last visit in pathfinder™2 prior to entry in pathfinder™7
* Planned surgery during the trial
* Major surgery performed within 4 weeks prior to screening
* Previous participation in this trial. Participation is defined as signed informed consent
* Any disorder, except for conditions associated with haemophilia A, which in the investigator's opinion might jeopardise patient's safety or compliance with the protocol

Primary outcomes:
measure: Area under the FVIII activity-time curve
timeFrame: From 0 to 96 hours post injection
Secondary outcomes:
measure: FVIII activity 30 min post administration - dose normalised to 50 U/kg
timeFrame: From time of trial product administration to 96 hours post-dose
measure: Area under the FVIII activity-time curve from 0 to infinity
timeFrame: From time of trial product administration to 96 hours post-dose
measure: Clearance in blood plasma of FVIII activity
timeFrame: From time of trial product administration to 96 hours post-dose
measure: Incremental recovery in blood plasma of FVIII activity
timeFrame: From time of trial product administration to 96 hours post-dose
measure: Terminal half-life
timeFrame: From time of trial product administration to 96 hours post-dose
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Iowa City
country: United States
facility: Novo Nordisk Investigational Site
state: Iowa
city: Baltimore
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: Dayton
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Nashville
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Århus N
country: Denmark
facility: Novo Nordisk Investigational Site
city: Bron Cedex
country: France
facility: Novo Nordisk Investigational Site
city: Nantes Cedex 1
country: France
facility: Novo Nordisk Investigational Site
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Frankfurt/M.
country: Germany
facility: Novo Nordisk Investigational Site
city: Homburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Groningen
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Málaga
country: Spain
facility: Novo Nordisk Investigational Site
Study officials:
References: