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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00837356
First Posted: February 5, 2009
Last Update Posted: February 10, 2017
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.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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 Intervention Phase
Congenital Bleeding Disorder Haemophilia A Drug: Advate® Drug: turoctocog alfa Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

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

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

Enrollment: 23
Study Start Date: March 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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®
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00837356


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

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00837356     History of Changes
Other Study ID Numbers: NN7008-3522
2008-002157-21 ( EudraCT Number )
First Submitted: February 4, 2009
First Posted: February 5, 2009
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
Coagulants