NCT02920398|CompletedPhase 1FDA Drug

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

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.

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN7088-40332015-005327-63U1111-1176-9253

Study Type

interventional

Target

Locations

6 countries

Sites

Timeline

RegisteredSep 2016

StartedOct 2016

CompletionApr 2017

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_1

Timeline

Completed

Started Oct 2016

Shorter than P25 for phase_1

Geographic Reach

6 countries

14 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6 months study duration

First Submitted

Initial submission to the registry

September 29, 2016

Completed

1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2016

Completed

4 days until next milestone

Study Start

First participant enrolled

October 4, 2016

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2017

Completed

Last Updated

December 15, 2017

Status Verified

December 1, 2017

Enrollment Period

6 months

First QC Date

September 29, 2016

Last Update Submit

December 14, 2017

Conditions

Congenital Bleeding Disorder Haemophilia A

Outcome Measures

Primary Outcomes (1)

Area under the FVIII activity-time curve
From 0 to 96 hours post injection

Secondary Outcomes (5)

FVIII activity 30 min post administration - dose normalised to 50 U/kg
From time of trial product administration to 96 hours post-dose
Area under the FVIII activity-time curve from 0 to infinity
From time of trial product administration to 96 hours post-dose
Clearance in blood plasma of FVIII activity
From time of trial product administration to 96 hours post-dose
Incremental recovery in blood plasma of FVIII activity
From time of trial product administration to 96 hours post-dose
Terminal half-life
From time of trial product administration to 96 hours post-dose

Study Arms (2)

N8-GP pivotal

EXPERIMENTAL

Drug: turoctocog alfa pegol

N8-GP commercial

ACTIVE COMPARATOR

Drug: turoctocog alfa pegol

Interventions

turoctocog alfa pegolDRUG

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.

N8-GP commercialN8-GP pivotal

Eligibility Criteria

Age12 Years+

Sexmale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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)

You may not qualify if:

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

Contact the study team to confirm eligibility.