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

A Multicentre, Open-label Trial Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02941354

Acronym

guardian ™9

Enrollment

Registered

2016-10-21

Start date

2016-10-10

Completion date

2017-06-20

Last updated

2019-01-30

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

Conditions

Congenital Bleeding Disorder, Haemophilia A

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.

Interventions

DRUGturoctocog alfa

Each subject will receive a single dose of turoctocog alfa as an intravenous (i.v.) bolus injection of 50 IU/kg.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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	—

Countries

Austria, Bulgaria, Germany, Serbia, Spain, Taiwan, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026