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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42941

Enrollment

Registered

2016-12-14

Start date

2017-01-05

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

blood clotting disorder Haemophilia A

Interventions

For each of the 2 pharmacokinetic sessions patients will administer an intravenous injection of turoctocog alfa pegol (once from the pivotal and once from the commercial process) at a dose of 50 U/k

Haemophilia A

Turoctocog alfa pegol

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. 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.;2. Ongoing participation in pathfinder*2 (NN7088-3859);3. Male, age * 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

Exclusion criteria: 1. FVIII inhibitors (*0.6 BU) at last visit in pathfinder*2 prior to entry in pathfinder*7;2. Planned surgery during the trial;3. Major surgery performed within 4 weeks prior to screening;4. Previous participation in this trial. Participation is defined as signed informed consent;5. 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

Design outcomes

Primary

Measure	Time frame
Primary endpoint The primary endpoint for each pharmacokinetic session is: - Area under the FVIII activity-time curve from 0 to 96 h post injection - dose normalised to 50 U/kg	—

Secondary

Measure	Time frame
Key secondary pharmacokinetic endpoints The key secondary pharmacokinetic endpoints are for the first and second pharmacokinetic periods, separately. The following pharmacokinetic endpoints will be derived based on plasma FVIII activity measured from time of trial product administration to 96 hours post-dose: - FVIII activity 30 min post administration - dose normalised to 50 U/kg - Area under the FVIII activity-time curve from 0 to infinity - Clearance - Incremental recovery - Terminal half-life	—

Measure

Time frame

Key secondary pharmacokinetic endpoints The key secondary pharmacokinetic endpoints are for the first and second pharmacokinetic periods, separately. The following pharmacokinetic endpoints will be derived based on plasma FVIII activity measured from time of trial product administration to 96 hours post-dose: - FVIII activity 30 min post administration - dose normalised to 50 U/kg - Area under the FVIII activity-time curve from 0 to infinity - Clearance - Incremental recovery - Terminal half-life

—

Countries

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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)