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

NCT ID: NCT02941354

Last Updated: 2019-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-10

Study Completion Date

2017-06-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Congenital Bleeding Disorder Haemophilia A

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Turoctocog alfa

Group Type EXPERIMENTAL

turoctocog alfa

Intervention Type DRUG

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

Interventions

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turoctocog alfa

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novo Nordisk Investigational Site

Chicago, Illinois, United States

Site Status

Novo Nordisk Investigational Site

Peoria, Illinois, United States

Site Status

Novo Nordisk Investigational Site

Memphis, Tennessee, United States

Site Status

Novo Nordisk Investigational Site

Richmond, Virginia, United States

Site Status

Novo Nordisk Investigational Site

Vienna, , Austria

Site Status

Novo Nordisk Investigational Site

Sofia, , Bulgaria

Site Status

Novo Nordisk Investigational Site

Bonn, , Germany

Site Status

Novo Nordisk Investigational Site

Hanover, , Germany

Site Status

Novo Nordisk Investigational Site

Belgrade, , Serbia

Site Status

Novo Nordisk Investigational Site

Madrid, , Spain

Site Status

Novo Nordisk Investigational Site

Málaga, , Spain

Site Status

Novo Nordisk Investigational Site

Valencia, , Spain

Site Status

Novo Nordisk Investigational Site

Vigo, , Spain

Site Status

Novo Nordisk Investigational Site

Changhua, , Taiwan

Site Status

Novo Nordisk Investigational Site

Taipei, , Taiwan

Site Status

Countries

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United States Austria Bulgaria Germany Serbia Spain Taiwan

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2015-004379-56

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1175-1191

Identifier Type: OTHER

Identifier Source: secondary_id

NN7008-4239

Identifier Type: -

Identifier Source: org_study_id

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