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
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