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 (pathfinder™7)

December 14, 2017 updated by: Novo Nordisk A/S

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Århus N, Denmark, 8200
        • Novo Nordisk Investigational Site
  • France
      • Bron Cedex, France, 69677
        • Novo Nordisk Investigational Site
      • Nantes Cedex 1, France, 44093
        • Novo Nordisk Investigational Site
  • Germany
      • Berlin, Germany, 10249
        • Novo Nordisk Investigational Site
      • Frankfurt/M., Germany, 60590
        • Novo Nordisk Investigational Site
      • Homburg, Germany, 66421
        • Novo Nordisk Investigational Site
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Novo Nordisk Investigational Site
  • Spain
      • Madrid, Spain, 28046
        • Novo Nordisk Investigational Site
      • Málaga, Spain, 29010
        • Novo Nordisk Investigational Site
  • United States
    • California
      • Torrance, California, United States, 90502-2004
        • Novo Nordisk Investigational Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Novo Nordisk Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Novo Nordisk Investigational Site
    • Ohio
      • Dayton, Ohio, United States, 45404
        • Novo Nordisk Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: N8-GP pivotal
Drug: turoctocog alfa pegol
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.
Active Comparator: N8-GP commercial
Drug: turoctocog alfa pegol
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the FVIII activity-time curve
Time Frame: From 0 to 96 hours post injection
From 0 to 96 hours post injection

Secondary Outcome Measures

Outcome Measure
Time Frame
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
From time of trial product administration to 96 hours post-dose
Area under the FVIII activity-time curve from 0 to infinity
Time Frame: From time of trial product administration to 96 hours post-dose
From time of trial product administration to 96 hours post-dose
Clearance in blood plasma of FVIII activity
Time Frame: From time of trial product administration to 96 hours post-dose
From time of trial product administration to 96 hours post-dose
Incremental recovery in blood plasma of FVIII activity
Time Frame: From time of trial product administration to 96 hours post-dose
From time of trial product administration to 96 hours post-dose
Terminal half-life
Time Frame: From time of trial product administration to 96 hours post-dose
From time of trial product administration to 96 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2016

Primary Completion (Actual)

April 7, 2017

Study Completion (Actual)

April 7, 2017

Study Registration Dates

First Submitted

September 29, 2016

First Submitted That Met QC Criteria

September 29, 2016

First Posted (Estimate)

September 30, 2016

Study Record Updates

Last Update Posted (Actual)

December 15, 2017

Last Update Submitted That Met QC Criteria

December 14, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN7088-4033
  • 2015-005327-63 (EudraCT Number)
  • U1111-1176-9253 (Other Identifier: WHO)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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