Back to resultsA Multi-centre, Comparative, Double Blind, Randomised Cross-over Trial Investigating Single Dose Pharmacokinetics and Safety of Turoctocog Alfa Pegol From the Pivotal Process and Turoctocog Alfa Pegol From the Commercial Process in Patients With Severe Haemophilia A (pathfinder™7)
Primary Purpose
Congenital Bleeding Disorder, Haemophilia A
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
turoctocog alfa pegol
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Bleeding Disorder
Eligibility Criteria
Inclusion Criteria:
- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- Ongoing participation in pathfinder™2
- Male, age at least 12 years at the time of signing informed consent (in certain countries the lower age limit will be 18 years, according to local requirements)
Exclusion Criteria:
- FVIII inhibitors (≥0.6 BU) at last visit in pathfinder™2 prior to entry in pathfinder™7
- Planned surgery during the trial
- Major surgery performed within 4 weeks prior to screening
- Previous participation in this trial. Participation is defined as signed informed consent
- Any disorder, except for conditions associated with haemophilia A, which in the investigator's opinion might jeopardise patient's safety or compliance with the protocol
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
- 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 2
Arm Type
Experimental
Active Comparator
Arm Label
N8-GP pivotal
N8-GP commercial
Arm Description
Outcomes
Primary Outcome Measures
Area under the FVIII activity-time curve
Secondary Outcome Measures
FVIII activity 30 min post administration - dose normalised to 50 U/kg
Area under the FVIII activity-time curve from 0 to infinity
Clearance in blood plasma of FVIII activity
Incremental recovery in blood plasma of FVIII activity
Terminal half-life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02920398
Brief Title
A Multi-centre, Comparative, Double Blind, Randomised Cross-over Trial Investigating Single Dose Pharmacokinetics and Safety of Turoctocog Alfa Pegol From the Pivotal Process and Turoctocog Alfa Pegol From the Commercial Process in Patients With Severe Haemophilia A
Acronym
pathfinder™7
Official Title
This Trial is Conducted in Europe and the United States of America. The Aim of This Trial is to Investigate Single Dose Pharmacokinetics (the Exposure of the Trial Drug in the Body) and Safety of Turoctocog Alfa Pegol From the Pivotal Process and Turoctocog Alfa Pegol From the Commercial Process in Patients With Severe Haemophilia A.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
October 4, 2016 (Actual)
Primary Completion Date
April 7, 2017 (Actual)
Study Completion Date
April 7, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Investigating single dose pharmacokinetics and safety of turoctocog alfa pegol from the pivotal process and turoctocog alfa pegol from the commercial process in patients with severe 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
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
N8-GP pivotal
Arm Type
Experimental
Arm Title
N8-GP commercial
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
turoctocog alfa pegol
Intervention Description
Administered as intravenous injections at a dose of 50 U/kg. Patients will receive each product in a randomised cross-over design for comparison of the pharmacokinetics between turoctocog alfa pegol from the pivotal process and turoctocog alfa pegol from the commercial process.
Primary Outcome Measure Information:
Title
Area under the FVIII activity-time curve
Time Frame
From 0 to 96 hours post injection
Secondary Outcome Measure Information:
Title
FVIII activity 30 min post administration - dose normalised to 50 U/kg
Time Frame
From time of trial product administration to 96 hours post-dose
Title
Area under the FVIII activity-time curve from 0 to infinity
Time Frame
From time of trial product administration to 96 hours post-dose
Title
Clearance in blood plasma of FVIII activity
Time Frame
From time of trial product administration to 96 hours post-dose
Title
Incremental recovery in blood plasma of FVIII activity
Time Frame
From time of trial product administration to 96 hours post-dose
Title
Terminal half-life
Time Frame
From time of trial product administration to 96 hours post-dose
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
Ongoing participation in pathfinder™2
Male, age at least 12 years at the time of signing informed consent (in certain countries the lower age limit will be 18 years, according to local requirements)
Exclusion Criteria:
FVIII inhibitors (≥0.6 BU) at last visit in pathfinder™2 prior to entry in pathfinder™7
Planned surgery during the trial
Major surgery performed within 4 weeks prior to screening
Previous participation in this trial. Participation is defined as signed informed consent
Any disorder, except for conditions associated with haemophilia A, which in the investigator's opinion might jeopardise patient's safety or compliance with the protocol
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Torrance
State/Province
California
ZIP/Postal Code
90502-2004
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Århus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Bron Cedex
ZIP/Postal Code
69677
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Berlin
ZIP/Postal Code
10249
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Frankfurt/M.
ZIP/Postal Code
60590
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Málaga
ZIP/Postal Code
29010
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
A Multi-centre, Comparative, Double Blind, Randomised Cross-over Trial Investigating Single Dose Pharmacokinetics and Safety of Turoctocog Alfa Pegol From the Pivotal Process and Turoctocog Alfa Pegol From the Commercial Process in Patients With Severe Haemophilia A
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