An Open Study to Investigate the Safety and Efficacy of Optivate® in Severe Haemophilia A Patients.

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

2001-09-30

Brief Summary

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The main objectives of this study are to compare the first and second recovery assessments and recovery when a subject changed batch and to assess whether haemostasis was achieved with Optivate® when treating a bleed. The secondary objectives are to evaluate the clinical tolerance and safety of Optivate®.

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Detailed Description

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Conditions

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Haemophilia A

Study Design

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Primary Study Purpose

TREATMENT

Study Groups

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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

* Immunocompetent with severe Haemophilia A without inhibitor to FVIII, at least 12 years of age, currently receiving FVIII concentrates and have more than 150 exposures. Subjects who require elective surgergy within 6 months of starting on OPTIVATE® are permitted to be included in this study providing that the surgery could be performed using OPTIVATE® as FVIII cover.