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

Phase 1

Completed

• Conditions: Congenital Bleeding Disorder; Haemophilia A
• Interventions: Drug: turoctocog alfa pegol

• Registration Number: NCT02920398
• Lead Sponsor: Novo Nordisk A/S

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-29
• Study First Submitted QC: 2016-09-29
• Study First Posted: 2016-09-30
• Study Start: 2016-10-04
• Primary Completion: 2017-04-07
• Study Completion: 2017-04-07
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-14
• Last Update Posted: 2017-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 21

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
N8-GP pivotal	turoctocog alfa pegol	-
N8-GP commercial	turoctocog alfa pegol	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Clearance 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
Area under the FVIII activity-time curve from 0 to infinity	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
FVIII activity 30 min post administration - dose normalised to 50 U/kg	From time of trial product administration to 96 hours post-dose

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇪🇸 Málaga, Spain