A Single Dose Trial of Recombinant Factor VIII (N8) in Japanese Subjects With Haemophilia A: An Extension to Trial NN7008-3543

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

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-10-31

Brief Summary

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This trial is conducted in Japan. The aim of this clinical trial is to investigate the pharmacokinetics (the effect of the investigated drug on the body) and safety of turoctocog alfa (recombinant factor VIII (N8)) in Japanese 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

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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recombinant factor VIII (N8)

Group Type EXPERIMENTAL

turoctocog alfa

Intervention Type DRUG

Subjects will receive recombinant factor VIII (N8) at a dose of 50 +/- 5 IU/kg body weight. Intravenous administration as a single bolus injection.

Interventions

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turoctocog alfa

Subjects will receive recombinant factor VIII (N8) at a dose of 50 +/- 5 IU/kg body weight. Intravenous administration as a single bolus injection.

Intervention Type DRUG

Other Intervention Names

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N8 recombinant factor VIII

Eligibility Criteria

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Inclusion Criteria

* Japanese subjects who have completed NN7008-3543
* No detectable inhibitors to factor VIII

Exclusion Criteria

* Congenital or acquired coagulation disorders other than haemophilia A
* Planned surgery during the trial period
* Receipt of any investigational drug other than recombinant factor VIII (N8) within 30 days of trial product administration

Minimum Eligible Age

12 Years

Maximum Eligible Age

66 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No