DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Congenital Bleeding Disorder; Haemophilia A

Intervention: Advate® (Drug); turoctocog alfa (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Novo Nordisk A/S

Official(s) and/or principal investigator(s):
Global Clinical Registry (GCR, 1452), Study Director, Affiliation: Novo Nordisk A/S

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.

Clinical Details

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 design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Recovery of FVIII 30 min after administration, half-life, AUC, and clearance

Secondary outcome: Inhibitor development

Eligibility

Minimum age: 12 Years. Maximum age: 55 Years. Gender(s): Male.

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®

Locations and Contacts

Hannover 30625, Germany

Tel-Hashomer 52621, Israel

Milano 20124, Italy

Zürich 8091, Switzerland

Additional Information

Clinical Trials at Novo Nordisk

Starting date: March 2009
Last updated: November 18, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017