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Completed

NCT Number: NCT02941354

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

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.

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Key information

Conditions

Congenital Bleeding Disorder Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Haemophilia A Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

turoctocog alfa

Drug

Each subject will receive a single dose of turoctocog alfa as an intravenous (i.v.) bolus injection of 50 IU/kg.

Primary outcomes

  1. Plasma FVIII activity at 30 minutes(C30min)

    Time frame: At 30 minutes post-dose

    Based on samples taken at pre-dose (-1hour), 15minutes, 30minutes, 1hour, 3hours, 6hours, 9hours, 24hours, 28hours, 48hours, 72hours post-dose

Secondary outcomes

  1. Area under the FVIII activity-time curve

    Time frame: From 0 up to 72 hours after administration

  2. Incremental recovery FVIII at 30 minutes (IR30min)

    Time frame: At 30 minutes post-dose

    Based on samples taken at pre-dose (-1hour), 15minutes, 30minutes, 1hour, 3hours, 6hours, 9hours, 24hours, 28hours, 48hours, 72hours post-dose

  3. Terminal half-life (t½) of FVIII

    Time frame: From 0 up to 72 hours after administration

  4. Clearance (CL) of FVIII

    Time frame: From 0 up to 72 hours after administration

  5. Apparent volume of distribution at steady state (Vss) of FVIII

    Time frame: From 0 up to 72 hours after administration

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Multicentre, Open-label Trial Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A

Acronym: guardian ™9

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 21, 2016
Registry last updated
Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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