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Replagal Maintenance in Fabry Disease

NCT00097890Phase 4

Key facts

Status: Completed
Start: Nov 2004
Countries: 1
Sponsor: National Institute of Neurological Disorders and Stroke
Modality: Replacement Enzymes

Drugs: agalsidase alfa
Conditions: Fabry disease (FD)

Overview

Phase 4, open-label, single-arm trial of agalsidase alfa in Fabry disease (FD), sponsored by National Institute of Neurological Disorders and Stroke. Primary endpoint: Safety evaluations. Started Nov 2004; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Replagal Maintenance
Replagal 0.2 mg/kg IV every other week

Who it enrols

Hemizygous males with Fabry disease, 18 years or older, who have completed 10 weeks of Replagal therapy in protocol TKT027.

Endpoints

Primary

Safety evaluationsEvery 2 weeks for 25 weeks

Secondary

Symptoms and pain questionnaire30 days post-treatment
Quantitative Sudomotor Axon Reflex Test30 days post-treatment
Electrocardiogram and Holter monitor30 days post-treatment
Blood and urine tests30 days post-treatment

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