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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.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01238367
First received: November 9, 2010
Last updated: February 9, 2017
Last verified: February 2017
  Purpose
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
Intervention Model: Single Group Assignment
Masking: No masking
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 ]
  • Incremental recovery [ Time Frame: Infusion, 30 minutes ]
  • In vivo t1/2 [ Time Frame: Infusion, 30 minutes ]
  • Total clearance (CL) [ Time Frame: Infusion, 30 minutes ]

Secondary Outcome Measures:
  • Maximal concentration [ Time Frame: at 15 minutes ]
  • Area under the curve [ Time Frame: from time zero to last ]
  • Number of adverse events [ Time Frame: from day -1 to day 3 (end of trial) ]

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

  Eligibility

Ages Eligible for Study:   12 Years to 66 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01238367

Locations
Japan
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
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01238367     History of Changes
Other Study ID Numbers: NN7008-3600
U1111-1117-1286 ( Other Identifier: WHO )
JapicCTI-101346 ( Other Identifier: JAPIC )
Study First Received: November 9, 2010
Last Updated: February 9, 2017

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

ClinicalTrials.gov processed this record on June 23, 2017