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Completed

NCT Number: NCT01692925

Investigation of the Pharmacokinetics of Turoctocog Alfa in Subjects With Haemophilia A

This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) of four lots of turoctocog alfa (a human recombinant coagulation factor VIII (FVIII)) 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, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
  • Male subjects with the diagnosis of severe haemophilia A (FVIII<1%) from age 18 years
  • Documented history of at least 150 exposure days to any other FVIII products (prevention or treatment of bleeds)
  • Immunocompetent (HIV (Human Immunodeficiency Virus) positive subjects should have CD4+ (Cluster of differentiation 4; a glycoprotein expressed on the surface) lymphocyte count >200/microL)

Exclusion criteria

  • Detectable inhibitors to FVIII (above or equal to 0.6 Bethesda Units (BU))
  • History of FVIII inhibitors
  • Severe current hepatic dysfunction or severe hepatic disease during the last 12 months
  • Known or suspected allergy to trial product (FVIII) or related products
  • Subjects receiving immune modulating medication or immune tolerance induction (ITI) regimens
  • Body mass index (BMI) above 30 kg/m^2

Treatment and study plan

turoctocog alfa

Drug

Trial product, 2000 IU/vial will be administered as an i.v. (intravenous) bolus injection.

Primary outcomes

  1. Dose normalised area under the curve (AUC/actual dose) based on chromogenic assay

    Time frame: up to 48 hours after i.v. administration

Secondary outcomes

  1. Dose normalised area under the FVIII activity-time curve (AUC/actual dose) based on one stage clot assay

    Time frame: up to 48 hours after i.v. administration

  2. Incremental recovery (IR30min) (defined as the peak FVIII level recorded 30 min after injection and reported as[IU/mL]/[IU/kg])

    Time frame: up to 48 hours after i.v. administration

  3. Area under the FVIII activity-time curve (AUC)

    Time frame: up to 48 hours after i.v. administration

  4. Terminal half-life of FVIII (t½)

    Time frame: up to 48 hours after i.v. administration

  5. Clearance of FVIII (CL)

    Time frame: up to 48 hours after i.v. administration

  6. Incidence of adverse events (AEs) including FVIII inhibitors

    Time frame: After approximately 3 months (at end of trial)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Multi-centre, Open-labelled Trial Investigating the Pharmacokinetics of Four Lots of Turoctocog Alfa in Subjects With Haemophilia A

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 26, 2012
Registry last updated
Feb 10, 2017

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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