Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A

Completed · Phase 1

Conditions studied: Congenital Bleeding Disorder, Haemophilia A

In brief

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.

Key facts

Study ID

NCT02941354

Run by

Novo Nordisk A/S

People needed

35

Starts

2016-10-10

Expected to finish

2017-06-20

Last updated by the study team

2019-01-30

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Chicago, Illinois, United States
• Novo Nordisk Investigational Site — Peoria, Illinois, United States
• Novo Nordisk Investigational Site — Memphis, Tennessee, United States
• Novo Nordisk Investigational Site — Richmond, Virginia, United States
• Novo Nordisk Investigational Site — Vienna, Austria
• Novo Nordisk Investigational Site — Sofia, Bulgaria
• Novo Nordisk Investigational Site — Bonn, Germany
• Novo Nordisk Investigational Site — Hanover, Germany
• Novo Nordisk Investigational Site — Belgrade, Serbia
• Novo Nordisk Investigational Site — Madrid, Spain
• Novo Nordisk Investigational Site — Málaga, Spain
• Novo Nordisk Investigational Site — Valencia, Spain
• Novo Nordisk Investigational Site — Vigo, Spain
• Novo Nordisk Investigational Site — Changhua, Taiwan
• Novo Nordisk Investigational Site — Taipei, Taiwan

Full record on ClinicalTrials.gov

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