Brief Title
A Single Dose Trial of NNC 0155-0000-0004 in Patients With Haemophilia A
Official Title
Multi-Centre, Open-Label, Randomised Trial Investigating the Pharmacokinetics of a Single Dose of NNC 0155-0000-0004 (N8) in Patients With Haemophilia A
Brief Summary
This trial is conducted in Asia and Europe. The aim of the trial is to investigate the pharmacokinetics (the rate at which the trial drug is eliminated from the body) of a single dose of turoctocog alfa (NNC 0155-0000-0004 (N8)) in patients with haemophilia A. Participation in this trial is dependent on previous participation in trial NN7008-3543 (Part B) (NCT00840086).
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Area under the curve
Secondary Outcome
Maximal concentration (Cmax)
Condition
Congenital Bleeding Disorder
Intervention
turoctocog alfa
Study Arms / Comparison Groups
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
4
Start Date
June 2011
Completion Date
September 2011
Primary Completion Date
September 2011
Eligibility Criteria
Inclusion Criteria: - Subjects with the diagnosis of severe haemophilia A (factor VIII less than or equal to 1%) - Body weight between 10 to 120 kg - Subjects who have completed NN7008-3543 (Part B) or subjects participating in NN7008-3568 after completion of NN7008-3543 (NCT00840086) Exclusion Criteria: - Known or suspected hypersensitivity to trial product(s) or related products - Previous participation in this trial defined as withdrawal - Planned surgery during the trial period (catheter, stents, ports, and dental extractions do not count as surgeries and will not exclude the subject) - Any disease or condition which, according to the trial physician's judgement, could imply a potential hazard to the subject, interfere with the trial participation or trial outcome
Gender
Male
Ages
12 Years - 56 Years
Accepts Healthy Volunteers
No
Contacts
Global Clinical Registry (GCR, 1452), ,
Location Countries
Malaysia
Location Countries
Malaysia
Administrative Informations
NCT ID
NCT01365520
Organization ID
NN7008-3893
Secondary IDs
2010-023921-39
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