A Single Dose Trial of NNC 0155-0000-0004 in Patients 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

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-09-30

Brief Summary

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This trial is conducted in Asia and Europe. The aim of the trial is to investigate the pharmacokinetics (the rate at which the trial drug is eliminated from the body) of a single dose of turoctocog alfa (NNC 0155-0000-0004 (N8)) in patients with haemophilia A. Participation in this trial is dependent on previous participation in trial NN7008-3543 (Part B) (NCT00840086).

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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

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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N8

Group Type EXPERIMENTAL

turoctocog alfa

Intervention Type DRUG

A single dose will be administered i.v. (into the vein). Subjects will be randomised to one of two lots of NNC 0155-0000-0004.

Interventions

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turoctocog alfa

A single dose will be administered i.v. (into the vein). Subjects will be randomised to one of two lots of NNC 0155-0000-0004.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with the diagnosis of severe haemophilia A (factor VIII less than or equal to 1%)
* Body weight between 10 to 120 kg
* Subjects who have completed NN7008-3543 (Part B) or subjects participating in NN7008-3568 after completion of NN7008-3543 (NCT00840086)

Exclusion Criteria

* Known or suspected hypersensitivity to trial product(s) or related products
* Previous participation in this trial defined as withdrawal
* Planned surgery during the trial period (catheter, stents, ports, and dental extractions do not count as surgeries and will not exclude the subject)
* Any disease or condition which, according to the trial physician's judgement, could imply a potential hazard to the subject, interfere with the trial participation or trial outcome

Minimum Eligible Age

12 Years

Maximum Eligible Age

56 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No