Investigation of the Pharmacokinetics of Turoctocog Alfa in Subjects With Haemophilia A

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

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-03-31

Brief Summary

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This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) of four lots of turoctocog alfa (a human recombinant coagulation factor VIII (FVIII)) 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

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lot A

Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days.

Group Type EXPERIMENTAL

turoctocog alfa

Intervention Type DRUG

Trial product, 2000 IU/vial will be administered as an i.v. (intravenous) bolus injection.

Lot B

Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days.

Group Type EXPERIMENTAL

turoctocog alfa

Intervention Type DRUG

Trial product, 2000 IU/vial will be administered as an i.v. (intravenous) bolus injection.

Lot C

Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days.

Group Type EXPERIMENTAL

turoctocog alfa

Intervention Type DRUG

Trial product, 2000 IU/vial will be administered as an i.v. (intravenous) bolus injection.

Lot D

Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days.

Group Type EXPERIMENTAL

turoctocog alfa

Intervention Type DRUG

Trial product, 3000 IU/vial will be administered as an i.v. (intravenous) bolus injection.

Interventions

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turoctocog alfa

Trial product, 2000 IU/vial will be administered as an i.v. (intravenous) bolus injection.

Intervention Type DRUG

turoctocog alfa

Trial product, 3000 IU/vial will be administered as an i.v. (intravenous) bolus injection.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* Male subjects with the diagnosis of severe haemophilia A (FVIII\<1%) from age 18 years
* Documented history of at least 150 exposure days to any other FVIII products (prevention or treatment of bleeds)
* Immunocompetent (HIV (Human Immunodeficiency Virus) positive subjects should have CD4+ (Cluster of differentiation 4; a glycoprotein expressed on the surface) lymphocyte count \>200/microL)

Exclusion Criteria

* Detectable inhibitors to FVIII (above or equal to 0.6 Bethesda Units (BU))
* History of FVIII inhibitors
* Severe current hepatic dysfunction or severe hepatic disease during the last 12 months
* Known or suspected allergy to trial product (FVIII) or related products
* Subjects receiving immune modulating medication or immune tolerance induction (ITI) regimens
* Body mass index (BMI) above 30 kg/m\^2

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No