Brief Title
A Single Dose Trial of Recombinant Factor VIII (N8) in Japanese Subjects With Haemophilia A: An Extension to Trial NN7008-3543
Official Title
Multi-centre, Open-label, Non-randomised Single Dose Trial Investigating the Pharmacokinetics of N8 in Japanese Subjects With Haemophilia A
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Area under the curve
Secondary Outcome
Maximal concentration
Condition
Congenital Bleeding Disorder
Intervention
turoctocog alfa
Study Arms / Comparison Groups
recombinant factor VIII (N8)
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
6
Start Date
November 2010
Completion Date
October 2011
Primary Completion Date
October 2011
Eligibility 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
Gender
Male
Ages
12 Years - 66 Years
Accepts Healthy Volunteers
No
Contacts
Global Clinical Registry (GCR, 1452), ,
Location Countries
Japan
Location Countries
Japan
Administrative Informations
NCT ID
NCT01238367
Organization ID
NN7008-3600
Secondary IDs
U1111-1117-1286
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S
Verification Date
February 2017