Clinical trial NCT03075670: A Trial Comparing Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B
Official title: A Trial Comparing the Pharmacokinetics of Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Congenital Bleeding Disorder
Haemophilia B
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2017-03-09
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
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 and the United States of America. The aim of this trial is to compare the pharmacokinetics (the exposure of the trial drug in the body) of nonacog beta pegol (N9-GP) and ALPROLIX® in patients with haemophilia B.


Eligibility criteria: Inclusion Criteria:

* Male, aged 18-70 years (both inclusive) at the time of signing informed consent
* Patients with the diagnosis of congenital haemophilia B with factor IX activity below or equal to 2%, based on medical records
* History of more than 150 exposures days to any factor IX containing products

Exclusion Criteria:

* Known history of factor IX inhibitors
* Inhibitors to factor IX (above or equal to 0.6 BU) at screening measured by the Nijmegen modified Bethesda method
* Immunocompromised (CD4+ T cells below or equal to 200/μL)
* Known congenital or acquired coagulation disorders other than haemophilia B
* Body mass index above 35 kg/m\^²

Primary outcomes:
measure: Area under the factor IX activity-time curve from 0 to infinity dose-normalised to 50 IU/kg
timeFrame: From time 0 (dosing) up to 240 hours post-dose
Secondary outcomes:
measure: Maximum activity dose-normalised to 50 IU/kg (Cmax,norm)
timeFrame: From time 0 (dosing) up to 240 hours post-dose
measure: Incremental recovery at 30 minutes (IR30min)
timeFrame: At 30 minutes
measure: Terminal half-life (t½)
timeFrame: From time 0 (dosing) up to 240 hours post-dose
measure: Clearance (CL)
timeFrame: From time 0 (dosing) up to 240 hours post-dose
measure: Area under the activity-time curve
timeFrame: From time 0 (dosing) up to 240 hours post-dose
measure: Maximum activity (Cmax)
timeFrame: From time 0 (dosing) up to 240 hours post-dose
measure: Activity at 30 minutes (C30min)
timeFrame: at 30 minutes
measure: Activity at 168 hours (C168h)
timeFrame: At 168 hours
measure: Incremental recovery at maximum activity (IRCmax)
timeFrame: From time 0 (dosing) up to 240 hours post-dose
measure: Time of maximum activity (tmax)
timeFrame: From time 0 (dosing) up to 240 hours post-dose
measure: Apparent volume of distribution during terminal phase (Vz)
timeFrame: From time 0 (dosing) up to 240 hours post-dose
measure: Apparent volume of distribution at steady-state (Vss)
timeFrame: From time 0 (dosing) up to 240 hours post-dose
measure: Mean residence time (MRT)
timeFrame: From time 0 (dosing) up to 240 hours post-dose
measure: Terminal elimination rate constant
timeFrame: From time 0 (dosing) up to 240 hours post-dose
measure: Area under the activity-time curve from 0 to infinity
timeFrame: From time 0 (dosing) up to 240 hours post-dose
measure: Area under the activity-time curve from 0 to t last
timeFrame: From time 0 (dosing) up to 240 hours post-dose
measure: Number of adverse events
timeFrame: From time 0 (dosing) up to 240 hours post-dose
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
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: East Lansing
country: United States
facility: Novo Nordisk Investigational Site
state: Michigan
city: Rochester
country: United States
facility: Novo Nordisk Investigational Site
state: Minnesota
city: Oklahoma City
country: United States
facility: Novo Nordisk Investigational Site
state: Oklahoma
city: Philadelphia
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Duisburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Hannover
country: Germany
facility: Novo Nordisk Investigational Site
city: Mörfelden-Walldorf
country: Germany
facility: Novo Nordisk Investigational Site
city: Zürich
country: Switzerland
facility: Novo Nordisk Investigational Site
Study officials:
References:
citation: Escuriola Ettingshausen C, Hegemann I, Simpson ML, Cuker A, Kulkarni R, Pruthi RK, Garly ML, Meldgaard RM, Persson P, Klamroth R. Favorable pharmacokinetics in hemophilia B for nonacog beta pegol versus recombinant factor IX-Fc fusion protein: A randomized trial. Res Pract Thromb Haemost. 2019 Mar 23;3(2):268-276. doi: 10.1002/rth2.12192. eCollection 2019 Apr.