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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02941354
Other study ID # NN7008-4239
Secondary ID 2015-004379-56U1
Status Completed
Phase Phase 1
First received
Last updated
Start date October 10, 2016
Est. completion date June 20, 2017

Study information

Verified date January 2019
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date June 20, 2017
Est. primary completion date June 20, 2017
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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


Intervention

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

Locations

Country Name City State
Austria Novo Nordisk Investigational Site Wien
Bulgaria Novo Nordisk Investigational Site Sofia
Germany Novo Nordisk Investigational Site Bonn
Germany Novo Nordisk Investigational Site Hannover
Serbia Novo Nordisk Investigational Site Belgrade
Spain Novo Nordisk Investigational Site Madrid
Spain Novo Nordisk Investigational Site Málaga
Spain Novo Nordisk Investigational Site Valencia
Spain Novo Nordisk Investigational Site Vigo
Taiwan Novo Nordisk Investigational Site Changhua
Taiwan Novo Nordisk Investigational Site Taipei
United States Novo Nordisk Investigational Site Chicago Illinois
United States Novo Nordisk Investigational Site Memphis Tennessee
United States Novo Nordisk Investigational Site Peoria Illinois
United States Novo Nordisk Investigational Site Richmond Virginia

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Area under the FVIII activity-time curve From 0 up to 72 hours after administration
Secondary Incremental recovery FVIII at 30 minutes (IR30min) 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 Terminal half-life (t½) of FVIII From 0 up to 72 hours after administration
Secondary Clearance (CL) of FVIII From 0 up to 72 hours after administration
Secondary Apparent volume of distribution at steady state (Vss) of FVIII From 0 up to 72 hours after administration
See also
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