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:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00837356
First received: February 4, 2009
Last updated: June 10, 2013
Last verified: June 2013
  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: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inhibitor development [ Time Frame: at 30 days ] [ Designated as safety issue: No ]

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 50IU/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 factor VIII
  • N8

  Eligibility

Ages Eligible for Study:   12 Years to 55 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00837356

Locations
Germany
Hannover, Germany, 30625
Israel
Tel-Hashomer, Israel, 52621
Italy
Milano, Italy, 20124
Switzerland
Zürich, Switzerland, 8091
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Marianne Willert, MSc Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00837356     History of Changes
Other Study ID Numbers: NN7008-3522, 2008-002157-21
Study First Received: February 4, 2009
Last Updated: June 10, 2013
Health Authority: Israel: Ministry of Health
Italy: National Institute of Health
Switzerland: Swissmedic
Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemophilia A
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Cardiovascular Diseases
Coagulation Protein Disorders
Genetic Diseases, Inborn
Hematologic Diseases
Hemorrhagic Disorders
Vascular Diseases
Factor VIII
Coagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014