Comparison of the Action of Drugs in the Body and Safety of N8 and Advate® in Haemophilia A Subjects

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

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-10-31

Brief Summary

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This trial is conducted in Europe and Asia. The aim of this clinical trial is to compare two recombinant factor VIII drugs, turoctocog alfa (recombinant factor VIII (N8)) with Advate®, in haemophilia A subjects, investigating the action and safety of the drugs.

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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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Advate®/turoctocog alfa

Group Type EXPERIMENTAL

Advate®

Intervention Type DRUG

Subjects will receive Advate® at a dose of 50 IU/kg body weight in the first session

turoctocog alfa

Intervention Type DRUG

After a washout period of 4 days, subjects will subsequently receive turoctocog alfa (recombinant factor VIII (N8)) at a dose of 50 IU/kg body weight in the second session

Interventions

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Advate®

Subjects will receive Advate® at a dose of 50 IU/kg body weight in the first session

Intervention Type DRUG

turoctocog alfa

After a washout period of 4 days, subjects will subsequently receive turoctocog alfa (recombinant factor VIII (N8)) at a dose of 50 IU/kg body weight in the second session

Intervention Type DRUG

Other Intervention Names

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recombinant FVIII N8

Eligibility Criteria

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Inclusion Criteria

* Severe haemophilia A (FVIII level less than or equal to 1%)
* Treatment history of more than 150 exposure days with recombinant or plasma-derived FVIII replacement products
* HIV or HCV negative, or if positive the patient is on a stable antiviral regimen at the time of the enrolment in the trial

Exclusion Criteria

* Presence of any bleeding disorder in addition to haemophilia A
* Inhibitor titre greater than or equal to 0.6 Bethesda Units (BU) at screening and past history of inhibitor
* Abnormal renal function tests
* Known hypersensitivity to Advate®

Minimum Eligible Age

12 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No