NCT02941354|CompletedPhase 1FDA Drug

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

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

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN7008-42392015-004379-56U1111-1175-1191

Study Type

interventional

Target

Locations

7 countries

Sites

Timeline

RegisteredOct 2016

StartedOct 2016

CompletionJun 2017

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_1

Timeline

Completed

Started Oct 2016

Shorter than P25 for phase_1

Geographic Reach

7 countries

15 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8 months study duration

Study Start

First participant enrolled

October 10, 2016

Completed

4 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2016

Completed

7 days until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2017

Completed

Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

8 months

First QC Date

October 14, 2016

Last Update Submit

January 29, 2019

Conditions

Congenital Bleeding Disorder Haemophilia A

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

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
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

Study Arms (1)

Turoctocog alfa

EXPERIMENTAL

Drug: turoctocog alfa

Interventions

turoctocog alfaDRUG

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

Turoctocog alfa

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.