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

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: November 9, 2010
Last updated: June 10, 2013
Last verified: June 2013

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.

Condition Intervention Phase
Congenital Bleeding Disorder
Haemophilia A
Drug: turoctocog alfa
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-centre, Open-label, Non-randomised Single Dose Trial Investigating the Pharmacokinetics of N8 in Japanese Subjects With Haemophilia A

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Area under the curve [ Time Frame: Infusion, 30 minutes ] [ Designated as safety issue: No ]
  • Incremental recovery [ Time Frame: Infusion, 30 minutes ] [ Designated as safety issue: No ]
  • In vivo t1/2 [ Time Frame: Infusion, 30 minutes ] [ Designated as safety issue: No ]
  • Total clearance (CL) [ Time Frame: Infusion, 30 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximal concentration [ Time Frame: at 15 minutes ] [ Designated as safety issue: No ]
  • Area under the curve [ Time Frame: from time zero to last ] [ Designated as safety issue: No ]
  • Number of adverse events [ Time Frame: from day -1 to day 3 (end of trial) ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: November 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: recombinant factor VIII (N8) Drug: turoctocog alfa
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


Ages Eligible for Study:   12 Years to 66 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01238367

Shinjuku-ku, Tokyo, Japan, 160 0023
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Shuichi Moriyama, MSc. Pharm. Novo Nordisk Pharma Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S Identifier: NCT01238367     History of Changes
Other Study ID Numbers: NN7008-3600, U1111-1117-1286, JapicCTI-101346
Study First Received: November 9, 2010
Last Updated: June 10, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemophilia A
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Cardiovascular Diseases
Coagulation Protein Disorders
Genetic Diseases, Inborn
Hematologic Diseases
Hemorrhagic Disorders
Vascular Diseases
Factor VIII
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses processed this record on November 24, 2014