Back to resultsA Single Dose Trial of NNC 0155-0000-0004 in Patients With Haemophilia A
Primary Purpose
Congenital Bleeding Disorder, Haemophilia A
Status
Completed
Phase
Phase 1
Locations
International
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:
- Subjects with the diagnosis of severe haemophilia A (factor VIII less than or equal to 1%)
- Body weight between 10 to 120 kg
- Subjects who have completed NN7008-3543 (Part B) or subjects participating in NN7008-3568 after completion of NN7008-3543 (NCT00840086)
Exclusion Criteria:
- Known or suspected hypersensitivity to trial product(s) or related products
- Previous participation in this trial defined as withdrawal
- Planned surgery during the trial period (catheter, stents, ports, and dental extractions do not count as surgeries and will not exclude the subject)
- Any disease or condition which, according to the trial physician's judgement, could imply a potential hazard to the subject, interfere with the trial participation or trial outcome
Sites / Locations
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
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 (Cmax)
Number of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01365520
Brief Title
A Single Dose Trial of NNC 0155-0000-0004 in Patients With Haemophilia A
Official Title
Multi-Centre, Open-Label, Randomised Trial Investigating the Pharmacokinetics of a Single Dose of NNC 0155-0000-0004 (N8) in Patients With Haemophilia A
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 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 Asia and Europe. The aim of the trial is to investigate the pharmacokinetics (the rate at which the trial drug is eliminated from the body) of a single dose of turoctocog alfa (NNC 0155-0000-0004 (N8)) in patients with haemophilia A. Participation in this trial is dependent on previous participation in trial NN7008-3543 (Part B) (NCT00840086).
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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
N8
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
turoctocog alfa
Intervention Description
A single dose will be administered i.v. (into the vein). Subjects will be randomised to one of two lots of NNC 0155-0000-0004.
Primary Outcome Measure Information:
Title
Area under the curve
Time Frame
Infusion, 48 hours
Title
Incremental recovery
Time Frame
Infusion, 30 minutes
Title
In vivo t1/2
Time Frame
Infusion, 48 hours
Title
Total clearance (CL)
Time Frame
Infusion, 48 hours
Secondary Outcome Measure Information:
Title
Maximal concentration (Cmax)
Time Frame
15 minutes after trial drug administration
Title
Number of adverse events
Time Frame
up to 48 hours after trial drug administration
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
56 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with the diagnosis of severe haemophilia A (factor VIII less than or equal to 1%)
Body weight between 10 to 120 kg
Subjects who have completed NN7008-3543 (Part B) or subjects participating in NN7008-3568 after completion of NN7008-3543 (NCT00840086)
Exclusion Criteria:
Known or suspected hypersensitivity to trial product(s) or related products
Previous participation in this trial defined as withdrawal
Planned surgery during the trial period (catheter, stents, ports, and dental extractions do not count as surgeries and will not exclude the subject)
Any disease or condition which, according to the trial physician's judgement, could imply a potential hazard to the subject, interfere with the trial participation or trial outcome
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
Kuala Lumpur
ZIP/Postal Code
50400
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
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 NNC 0155-0000-0004 in Patients With Haemophilia A
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