A Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age 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

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Brief Summary

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The main objectives of this study are:

* to assess Optivate® consumption (IU/kg consumed per month for prophylactic and on-demand therapy and dose at each bleed).
* to assess clinical outcome when treating a bleed with Optivate®.
* to evaluate Optivate® in terms of clinical tolerance and safety in children under the age of 6 years. .
* to assess FVIII inhibitor development during the study.

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Detailed Description

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Conditions

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Haemophilia A

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

* Children under the age of 6 years with a diagnosis of severe Haemophilia A. Subjects who required FVIII therapy and did not demonstrate inhibitors to FVIII.

Children with history of inhibitors to FVIII or clinically significant renal or liver disease were not eligible to participate in the study.