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Completed

NCT Number: NCT01238367

A Single Dose Trial of Recombinant Factor VIII (N8) in Japanese Subjects With Haemophilia A: An Extension to Trial NN7008-3543

This trial is conducted in Japan. The aim of this clinical trial is to investigate the pharmacokinetics (the effect of the investigated drug on the body) and safety of turoctocog alfa (recombinant factor VIII (N8)) in Japanese 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

12 year–66 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site, Itabashi-ku, Tokyo, Japan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Japanese subjects who have completed NN7008-3543
  • No detectable inhibitors to factor VIII

Exclusion criteria

  • Congenital or acquired coagulation disorders other than haemophilia A
  • Planned surgery during the trial period
  • Receipt of any investigational drug other than recombinant factor VIII (N8) within 30 days of trial product administration

Treatment and study plan

turoctocog alfa

Drug

Subjects will receive recombinant factor VIII (N8) at a dose of 50 +/- 5 IU/kg body weight. Intravenous administration as a single bolus injection.

Other names: N8, recombinant factor VIII

Primary outcomes

  1. Area under the curve

    Time frame: Infusion, 30 minutes

  2. Incremental recovery

    Time frame: Infusion, 30 minutes

  3. In vivo t1/2

    Time frame: Infusion, 30 minutes

  4. Total clearance (CL)

    Time frame: Infusion, 30 minutes

Secondary outcomes

  1. Maximal concentration

    Time frame: at 15 minutes

  2. Area under the curve

    Time frame: from time zero to last

  3. Number of adverse events

    Time frame: from day -1 to day 3 (end of trial)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Multi-centre, Open-label, Non-randomised Single Dose Trial Investigating the Pharmacokinetics of N8 in Japanese Subjects With Haemophilia A

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 10, 2010
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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