Comparison of the Action of Drugs in the Body and Safety of N8 and Advate® in Haemophilia A Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00837356
Recruitment Status : Completed
First Posted : February 5, 2009
Last Update Posted : February 10, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

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.

Condition or disease Intervention/treatment Phase
Congenital Bleeding Disorder Haemophilia A Drug: Advate® Drug: turoctocog alfa Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-centre, Multi-national Open-label Sequential Trial Comparing Pharmacokinetics and Safety of N8 and Advate® in Subjects With Haemophilia A
Study Start Date : March 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Arm Intervention/treatment
Experimental: Advate®/turoctocog alfa Drug: Advate®
Subjects will receive Advate® at a dose of 50 IU/kg body weight in the first session
Drug: turoctocog alfa
After a washout period of 4 days, subjects will subsequently receive turoctocog alfa (recombinant factor VIII (N8)) at a dose of 50 IU/kg body weight in the second session
Other Names:
  • recombinant FVIII
  • N8

Primary Outcome Measures :
  1. Recovery of FVIII 30 min after administration, half-life, AUC, and clearance [ Time Frame: at 30 days ]

Secondary Outcome Measures :
  1. Inhibitor development [ Time Frame: at 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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®

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00837356

Novo Nordisk Investigational Site
Berlin, Germany, 10249
Novo Nordisk Investigational Site
Hannover, Germany, 30625
Novo Nordisk Investigational Site
Tel-Hashomer, Israel, 52621
Novo Nordisk Investigational Site
Firenze, Italy, 50134
Novo Nordisk Investigational Site
Milano, Italy, 20124
Novo Nordisk Investigational Site
Madrid, Spain, 28046
Novo Nordisk Investigational Site
Zürich, Switzerland, 8091
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
Responsible Party: Novo Nordisk A/S Identifier: NCT00837356     History of Changes
Other Study ID Numbers: NN7008-3522
2008-002157-21 ( EudraCT Number )
First Posted: February 5, 2009    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017

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