Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A

Phase 1

Completed

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

• Registration Number: NCT02941354
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted globally. The aim of this trial is evaluating the pharmacokinetics (the exposure of the trial drug in the body) of NovoEight® (turoctocog alfa) in relation to BMI (body mass index) in subjects with haemophilia A.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-10
• Study First Submitted: 2016-10-14
• Study First Submitted QC: 2016-10-20
• Study First Posted: 2016-10-21
• Primary Completion: 2017-06-20
• Study Completion: 2017-06-20
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 35

Inclusion Criteria

• Male, age at least 18 years at the time of signing informed consent
• History of more than 150 exposure days to any factor VIII products
• Subjects with the diagnosis of congenital haemophilia A with factor VIII activity below 1%, based on medical records

Exclusion Criteria

• Known history of factor VIII inhibitors
• Inhibitors to factor VIII (above or equal to 0.6 BU (Bethesda units)) at screening measured by the Nijmegen modified Bethesda method
• Known congenital or acquired coagulation disorders other than haemophilia A
• Previous participation in pharmacokinetic sessions with turoctocog alfa in another trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Turoctocog alfa	turoctocog alfa	-

Primary Outcome Measures

Name	Time	Method
Plasma FVIII activity at 30 minutes(C30min)	At 30 minutes post-dose	Based on samples taken at pre-dose (-1hour), 15minutes, 30minutes, 1hour, 3hours, 6hours, 9hours, 24hours, 28hours, 48hours, 72hours post-dose

Secondary Outcome Measures

Name	Time	Method
Area under the FVIII activity-time curve	From 0 up to 72 hours after administration
Incremental recovery FVIII at 30 minutes (IR30min)	At 30 minutes post-dose	Based on samples taken at pre-dose (-1hour), 15minutes, 30minutes, 1hour, 3hours, 6hours, 9hours, 24hours, 28hours, 48hours, 72hours post-dose
Terminal half-life (t½) of FVIII	From 0 up to 72 hours after administration
Clearance (CL) of FVIII	From 0 up to 72 hours after administration
Apparent volume of distribution at steady state (Vss) of FVIII	From 0 up to 72 hours after administration

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇨🇳 Taipei, Taiwan