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

Congenital Bleeding Disorder Clinical Trial

Official title:

A Multi-centre, Multi-national Open-label Sequential Trial Comparing Pharmacokinetics and Safety of N8 and Advate® in Subjects With Haemophilia A

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00837356
• Other study ID #: NN7008-3522
• Secondary ID: 2008-002157-21
• Status: Completed
• Phase: Phase 1
• First received: February 4, 2009
• Last updated: February 9, 2017
• Start date: March 2009
• Est. completion date: October 2009

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 12 Years to 55 Years

Eligibility

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®

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Congenital Bleeding Disorder
• Haemophilia A
• Hemophilia A
• Hemostatic Disorders

Intervention

Drug:
• Advate®
Subjects will receive Advate® at a dose of 50 IU/kg body weight in the first session
• 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

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Berlin
Germany	Novo Nordisk Investigational Site	Hannover
Israel	Novo Nordisk Investigational Site	Tel-Hashomer
Italy	Novo Nordisk Investigational Site	Firenze
Italy	Novo Nordisk Investigational Site	Milano
Spain	Novo Nordisk Investigational Site	Madrid
Switzerland	Novo Nordisk Investigational Site	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Germany,  Israel,  Italy,  Spain,  Switzerland, 

References & Publications (1)

Martinowitz U, Bjerre J, Brand B, Klamroth R, Misgav M, Morfini M, Santagostino E, Tiede A, Viuff D. Bioequivalence between two serum-free recombinant factor VIII preparations (N8 and ADVATE®)--an open-label, sequential dosing pharmacokinetic study in pat — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery of FVIII 30 min after administration, half-life, AUC, and clearance		at 30 days
Secondary	Inhibitor development		at 30 days

External Links

•   Clinical Trials at Novo Nordisk