Trial Information

A Multi-center, Open-Label, Randomized study evaluating the Safety and Efficacy of Three Dosing Regimens of Replagal Enzyme Replacement Therapy in Adult Patients with Fabry Disease.

Replagal Enzyme Replacement Therapy in Adult Patients with Fabry Disease

Patients who meet the following criteria will be eligible for study participation:

The patient is = 18 years-old.
The patient is a hemizygous male with Fabry disease as confirmed by a deficiency of a-galactosidase-A activity measured in serum, leukocytes, or fibroblasts. Male patients who do not already have a documented deficiency of a-galactosidase-A activity will provide a blood sample during Screening for determination of a-galactosidase-A activity level in their serum.

Patient Exclusion Criteria:

The patient has documented NYHA functional class IV heart failure symptoms.
The patient has clinically significant systemic hypertension defined as an untreated resting blood pressure (BP) > 160 / 110 mmHg or poorly controlled hypertension defined as a BP > 150 / 100, while receiving medication(s) for treatment of hypertension.
The patient has hemodynamically significant valvular stenosis or regurgitation by Doppler echocardiography.
The patient is morbidly obese, defined as having a body mass index > 39 kg/m2.
The patient has a known autosomal dominant sarcoplasmic contractile protein gene mutation.
The patient has received treatment with any investigational drug or device within the 30 days prior to study entry.
The patient is unable to comply with the protocol, e.g., has a clinically relevant

Tammy DeLozier, Clinical Operations Manager
AKDHC
3003 N. Central Avenue, Ste. 400
Phoenix, AZ 85012
Phone: (602) 997-0484
Fax: (602) 200-3652
Email: tdelozier@akdhc.com

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Research Center Information: AKDHC

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