Status and phase
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This is a multi-center, open label, phase IV study conducted to evaluate the efficacy and safety of agalsidase beta (Fabrazyme [recombinant form]) administered by intravenous drip infusion in participants with cardiac Fabry disease.
Participants participated for 4 weeks or less in the baseline period and 156 weeks for the treatment period.
Enrollment
Sex
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Volunteers
Inclusion criteria
Participants definitively diagnosed with cardiac Fabry disease (who fulfill all of the following criteria)
Participants with interventricular and posterior wall thickness of at least 13 millimeter (mm) on echocardiography within 3 months before signed date to informed consent
Participants in whom cardiac function was rated as Class I or II according to the New York Heart Association (NYHA) classification when giving informed consent.
Participants classification: inpatients and outpatients
Participants who had given written informed consent before the study-related baseline tests.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
6 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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