A Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in 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

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2001-10-31

Brief Summary

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The main objective of the study is to compare the pharmacokinetics of Optivate® with the subject's current FVIII concentrate when given as a bolus dose of 50IU/kg. The secondary objective is to compare the first and second pharmacokinetic assessments on Optivate® (and recovery if a subject changes batch) to evaluate Optivate® in terms of clinical tolerance and safety.

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Detailed Description

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Conditions

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Von Willebrand Disease

Study Design

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Primary Study Purpose

TREATMENT

Study Groups

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Current Factor VIII

Optivate® (Human Coagulation Factor VIII)

Group Type ACTIVE_COMPARATOR

Optivate® (Human Coagulation Factor VIII)

Intervention Type BIOLOGICAL

Optivate®

Optivate® (Human Coagulation Factor VIII)

Group Type EXPERIMENTAL

Optivate® (Human Coagulation Factor VIII)

Intervention Type BIOLOGICAL

Interventions

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Optivate® (Human Coagulation Factor VIII)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Previously treated subjects with severe Haemophilia A (\<2% basal FVIII activity) without inhibitor to Factor VIII, at least 12 years of age, currently receiving FVIII concentrate and with more than 20 exposure days.