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: June 10, 2013
Last verified: June 2013
  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
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

  Eligibility

Ages Eligible for Study:   12 Years to 66 Years
Genders 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
Shinjuku-ku, Tokyo, Japan, 160 0023
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Shuichi Moriyama, MSc. Pharm. Novo Nordisk Pharma Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov 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
Hemostatic Disorders
Hemorrhagic Disorders
Hemophilia A
Hemorrhage
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Pathologic Processes
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014