Back to resultsComparison of the Action of Drugs in the Body and Safety of N8 and Advate® in Haemophilia A Subjects
Primary Purpose
Congenital Bleeding Disorder, Haemophilia A
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Advate®
turoctocog alfa
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Bleeding Disorder
Eligibility 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®
Sites / Locations
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Advate®/turoctocog alfa
Arm Description
Outcomes
Primary Outcome Measures
Recovery of FVIII 30 min after administration, half-life, AUC, and clearance
Secondary Outcome Measures
Inhibitor development
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00837356
Brief Title
Comparison of the Action of Drugs in the Body and Safety of N8 and Advate® in Haemophilia A Subjects
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 Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Bleeding Disorder, Haemophilia A
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Advate®/turoctocog alfa
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Advate®
Intervention Description
Subjects will receive Advate® at a dose of 50 IU/kg body weight in the first session
Intervention Type
Drug
Intervention Name(s)
turoctocog alfa
Other Intervention Name(s)
recombinant FVIII, N8
Intervention Description
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
Primary Outcome Measure Information:
Title
Recovery of FVIII 30 min after administration, half-life, AUC, and clearance
Time Frame
at 30 days
Secondary Outcome Measure Information:
Title
Inhibitor development
Time Frame
at 30 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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®
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Berlin
ZIP/Postal Code
10249
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Tel-Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Milano
ZIP/Postal Code
20124
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
21443634
Citation
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(R))--an open-label, sequential dosing pharmacokinetic study in patients with severe haemophilia A. Haemophilia. 2011 Nov;17(6):854-9. doi: 10.1111/j.1365-2516.2011.02495.x. Epub 2011 Mar 28.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Comparison of the Action of Drugs in the Body and Safety of N8 and Advate® in Haemophilia A Subjects
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