Brief Title
Comparison of the Action of Drugs in the Body and Safety of N8 and Advate® in Haemophilia A Subjects
Official Title
A Multi-centre, Multi-national Open-label Sequential Trial Comparing Pharmacokinetics and Safety of N8 and Advate® in Subjects With Haemophilia A
Brief Summary
This trial is conducted in Europe and Asia. The aim of this clinical trial is to compare two recombinant factor VIII drugs, turoctocog alfa (recombinant factor VIII (N8)) with Advate®, in haemophilia A subjects, investigating the action and safety of the drugs.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Recovery of FVIII 30 min after administration, half-life, AUC, and clearance
Secondary Outcome
Inhibitor development
Condition
Congenital Bleeding Disorder
Intervention
Advate®
Study Arms / Comparison Groups
Advate®/turoctocog alfa
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
23
Start Date
March 2009
Completion Date
October 2009
Primary Completion Date
October 2009
Eligibility Criteria
Inclusion Criteria: - Severe haemophilia A (FVIII level less than or equal to 1%) - Treatment history of more than 150 exposure days with recombinant or plasma-derived FVIII replacement products - HIV or HCV negative, or if positive the patient is on a stable antiviral regimen at the time of the enrolment in the trial Exclusion Criteria: - Presence of any bleeding disorder in addition to haemophilia A - Inhibitor titre greater than or equal to 0.6 Bethesda Units (BU) at screening and past history of inhibitor - Abnormal renal function tests - Known hypersensitivity to Advate®
Gender
Male
Ages
12 Years - 55 Years
Accepts Healthy Volunteers
No
Contacts
Global Clinical Registry (GCR, 1452), ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT00837356
Organization ID
NN7008-3522
Secondary IDs
2008-002157-21
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