Safety, tolerability, and pharmacokinetics study of single and multiple subcutaneous doses of turoctocog alfa pegol in patients with haemophilia A - alleviate 1

ovo Nordisk A/S0 sites36 target enrollmentDecember 12, 2017

Overview

No summary available.

Registry

who.int

Start Date

December 12, 2017

End Date

October 15, 2018

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•1\. Male, age above or equal to 18 years at the time of signing informed consent,(part A).
•2\. Male, age above or equal to 12 years at the time of signing informed consent,(part B).
•3\. Diagnosis of congenital haemophilia A based on medical records (FVIII activity \<1%).
•4\. History of more than 150 exposure days to any FVIII containing products.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 3
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 45
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

•1\. Previous participation in this trial. Participation is defined as signed informed consent. (Patients who have completed part A are allowed to also participate in part B. If so, a separate informed consent covering part B must be signed.)
•2\. Immune compromised patients due to human immunodeficiency virus (HIV) infection (defined as viral load \=400\.000 copies/mL and/or cluster of differentiation 4\+ (CD4\+) lymphocyte count \=200/µL performed at screening or defined by medical records no older than 6 months)
•3\. Any history of FVIII inhibitors (defined by medical records within 8 years of randomisation)
•4\. Inhibitors to FVIII (\= 0\.6 Bethesda unit (BU)) at screening, measured by Nijmegen modified Bethesda method at central laboratory.