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
• 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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Congenital Bleeding Disorder
• Haemophilia A
• Hemophilia A
• Hemostatic Disorders

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