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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01238367
Recruitment Status : Completed
First Posted : November 10, 2010
Last Update Posted : February 10, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment Phase
Congenital Bleeding Disorder Haemophilia A Drug: turoctocog alfa Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Arm Intervention/treatment
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

Primary Outcome Measures :
  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 Outcome Measures :
  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) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 66 Years   (Child, Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01238367

Novo Nordisk Investigational Site
Itabashi-ku, Tokyo, Japan, 173 8606
Novo Nordisk Investigational Site
Kashihara-shi, Nara, Japan, 634 8522
Novo Nordisk Investigational Site
Maebashi-shi, Gunma, Japan, 371-8511
Novo Nordisk Investigational Site
Shinjuku-ku, Tokyo, Japan, 160 0023
Novo Nordisk Investigational Site
Shizuoka-shi, Shizuoka, Japan, 4208660
Novo Nordisk Investigational Site
Suginami-ku, Tokyo, Japan, 1670035
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
Responsible Party: Novo Nordisk A/S Identifier: NCT01238367     History of Changes
Other Study ID Numbers: NN7008-3600
U1111-1117-1286 ( Other Identifier: WHO )
JapicCTI-101346 ( Other Identifier: JAPIC )
First Posted: November 10, 2010    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Vascular Diseases
Cardiovascular Diseases
Factor VIII