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 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

October 4, 2016

Primary Completion Date

April 7, 2017

Study Completion Date

April 7, 2017

Conditions

Congenital Bleeding DisorderHaemophilia A

Interventions

DRUG

turoctocog alfa pegol

Administered as intravenous injections at a dose of 50 U/kg. Patients will receive each product in a randomised cross-over design for comparison of the pharmacokinetics between turoctocog alfa pegol from the pivotal process and turoctocog alfa pegol from the commercial process.

Trial Locations (14)

8200

Novo Nordisk Investigational Site, Århus N

10249

Novo Nordisk Investigational Site, Berlin

21287

Novo Nordisk Investigational Site, Baltimore

28046

Novo Nordisk Investigational Site, Madrid

29010

Novo Nordisk Investigational Site, Málaga

37232

Novo Nordisk Investigational Site, Nashville

44093

Novo Nordisk Investigational Site, Nantes

45404

Novo Nordisk Investigational Site, Dayton

52242

Novo Nordisk Investigational Site, Iowa City

60590

Novo Nordisk Investigational Site, Frankfurt/M.

66421

Novo Nordisk Investigational Site, Homburg

69677

Novo Nordisk Investigational Site, Bron

90502-2004

Novo Nordisk Investigational Site, Torrance

9713 GZ

Novo Nordisk Investigational Site, Groningen