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

Completed

• Conditions: blood clotting disorder; Haemophilia A; 10064477

• Registration Number: NL-OMON42941
• Lead Sponsor: ovo Nordisk

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 2

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint<br /><br>The primary endpoint for each pharmacokinetic session is:<br /><br>- Area under the FVIII activity-time curve from 0 to 96 h post injection - dose<br /><br>normalised to 50 U/kg </p><br>

Secondary Outcome Measures

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