Back to resultsA Single Dose Trial of Recombinant Factor VIII (N8) in Japanese Subjects With Haemophilia A: An Extension to Trial NN7008-3543
Primary Purpose
Congenital Bleeding Disorder, Haemophilia A
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
turoctocog alfa
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Bleeding Disorder
Eligibility Criteria
Inclusion Criteria:
- Japanese subjects who have completed NN7008-3543
- No detectable inhibitors to factor VIII
Exclusion Criteria:
- Congenital or acquired coagulation disorders other than haemophilia A
- Planned surgery during the trial period
- Receipt of any investigational drug other than recombinant factor VIII (N8) within 30 days of trial product administration
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
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
recombinant factor VIII (N8)
Arm Description
Outcomes
Primary Outcome Measures
Area under the curve
Incremental recovery
In vivo t1/2
Total clearance (CL)
Secondary Outcome Measures
Maximal concentration
Area under the curve
Number of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01238367
Brief Title
A Single Dose Trial of Recombinant Factor VIII (N8) in Japanese Subjects With Haemophilia A: An Extension to Trial NN7008-3543
Official Title
Multi-centre, Open-label, Non-randomised Single Dose Trial Investigating the Pharmacokinetics of N8 in Japanese Subjects With Haemophilia A
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (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 Japan. The aim of this clinical trial is to investigate the pharmacokinetics (the effect of the investigated drug on the body) and safety of turoctocog alfa (recombinant factor VIII (N8)) in Japanese subjects with haemophilia A.
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
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
recombinant factor VIII (N8)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
turoctocog alfa
Other Intervention Name(s)
N8, recombinant factor VIII
Intervention Description
Subjects will receive recombinant factor VIII (N8) at a dose of 50 +/- 5 IU/kg body weight. Intravenous administration as a single bolus injection.
Primary Outcome Measure Information:
Title
Area under the curve
Time Frame
Infusion, 30 minutes
Title
Incremental recovery
Time Frame
Infusion, 30 minutes
Title
In vivo t1/2
Time Frame
Infusion, 30 minutes
Title
Total clearance (CL)
Time Frame
Infusion, 30 minutes
Secondary Outcome Measure Information:
Title
Maximal concentration
Time Frame
at 15 minutes
Title
Area under the curve
Time Frame
from time zero to last
Title
Number of adverse events
Time Frame
from day -1 to day 3 (end of trial)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Japanese subjects who have completed NN7008-3543
No detectable inhibitors to factor VIII
Exclusion Criteria:
Congenital or acquired coagulation disorders other than haemophilia A
Planned surgery during the trial period
Receipt of any investigational drug other than recombinant factor VIII (N8) within 30 days of trial product administration
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
Itabashi-ku, Tokyo
ZIP/Postal Code
173 8606
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Kashihara-shi, Nara
ZIP/Postal Code
634 8522
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Maebashi-shi, Gunma
ZIP/Postal Code
371-8511
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Shinjuku-ku, Tokyo
ZIP/Postal Code
160 0023
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Shizuoka-shi, Shizuoka
ZIP/Postal Code
4208660
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Suginami-ku, Tokyo
ZIP/Postal Code
1670035
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
25495795
Citation
Jimenez-Yuste V, Lejniece S, Klamroth R, Suzuki T, Santagostino E, Karim FA, Saugstrup T, Moss J. The pharmacokinetics of a B-domain truncated recombinant factor VIII, turoctocog alfa (NovoEight(R)), in patients with hemophilia A. J Thromb Haemost. 2015 Mar;13(3):370-9. doi: 10.1111/jth.12816. Epub 2015 Feb 13.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
A Single Dose Trial of Recombinant Factor VIII (N8) in Japanese Subjects With Haemophilia A: An Extension to Trial NN7008-3543
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