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NCT02920398 Clinical 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

Congenital Bleeding Disorder Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02920398
Other study ID # NN7088-4033
Secondary ID 2015-005327-63U1
Status Completed
Phase Phase 1
First received September 29, 2016
Last updated December 14, 2017
Start date October 4, 2016
Est. completion date April 7, 2017

Study information
Verified date December 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 21
Est. completion date April 7, 2017
Est. primary completion date April 7, 2017
Accepts healthy volunteers No
Gender Male
Age group 12 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Denmark Novo Nordisk Investigational Site Århus N
France Novo Nordisk Investigational Site Bron Cedex
France Novo Nordisk Investigational Site Nantes Cedex 1
Germany Novo Nordisk Investigational Site Berlin
Germany Novo Nordisk Investigational Site Frankfurt/M.
Germany Novo Nordisk Investigational Site Homburg
Netherlands Novo Nordisk Investigational Site Groningen
Spain Novo Nordisk Investigational Site Madrid
Spain Novo Nordisk Investigational Site Málaga
United States Novo Nordisk Investigational Site Baltimore Maryland
United States Novo Nordisk Investigational Site Dayton Ohio
United States Novo Nordisk Investigational Site Iowa City Iowa
United States Novo Nordisk Investigational Site Nashville Tennessee
United States Novo Nordisk Investigational Site Torrance California

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Denmark,  France,  Germany,  Netherlands,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Area under the FVIII activity-time curve From 0 to 96 hours post injection
Secondary FVIII activity 30 min post administration - dose normalised to 50 U/kg From time of trial product administration to 96 hours post-dose
Secondary Area under the FVIII activity-time curve from 0 to infinity From time of trial product administration to 96 hours post-dose
Secondary Clearance in blood plasma of FVIII activity From time of trial product administration to 96 hours post-dose
Secondary Incremental recovery in blood plasma of FVIII activity From time of trial product administration to 96 hours post-dose
Secondary Terminal half-life From time of trial product administration to 96 hours post-dose
See also
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Completed NCT01228669 - Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or B Phase 1
Completed NCT01988532 - Impact of Pain on Functional Impairment and Quality of Life in Adults With Hemophilia N/A
Completed NCT01234545 - Observational Study Describing the Usual Clinical Practice Use of NovoSeven® in the Home Treatment of Joint Bleeds in Patients With Haemophilia A or B and Inhibitors N/A
Completed NCT01779921 - Treatment of Congenital Factor VII Deficiency N/A
Completed NCT01563471 - Safety and Tolerability of Intravenous Doses of Activated Recombinant Human Factor VII in Healthy Volunteers Phase 1
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Completed NCT01238367 - A Single Dose Trial of Recombinant Factor VIII (N8) in Japanese Subjects With Haemophilia A: An Extension to Trial NN7008-3543 Phase 1