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A Phase III Trial to Assess the Safety and Efficacy of Plant Cell Expressed GCD in Patients With Gaucher Disease

Last updated on February 20, 2019

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Study Location
University Research Foundation for Lysosomal Storage Diseases
Coral Springs, Florida, 33065 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Gaucher Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Males and females, 18 years or older

- Confirmed enzymatic diagnosis of Gaucher disease

- Splenomegaly defined as greater than eight times the expected volume (measured volume
divided by estimated volume (0.2% of body weight)] as determined by MRI volumetric
analysis

- Female patients of child-bearing potential who agree to use a medically acceptable
method of contraception

- Thrombocytopenia (defined as platelet counts below the lower limit of normal) and/or
anemia (defined by hemoglobin level at least 1 g/dL below normal range according to
sex and age).

- Patients who have not received ERT in the past or patients whoc have not received ERT
in the past 12 months and have a negative anti-glucocerebrosidase antibody test.

- Patients who have not received substrate reduction therapy (SRT) in the past 12
months.

- Ability to provide a written informed consent.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Currently taking another experimental drug for any condition

- Pregnant or nursing

- Presence of HIV and/or, HBsAg and/or hepatitis C infections

- Presence of severe neurological signs and symptoms, defined as complete ocular
paralysis, overt myoclonus or history of seizures, characteristic of neuronopathic
Gaucher disease.

- Previous anaphylactoid reaction to Cerezyme® or Ceredase®.

- History of allergy to carrots.

NCT00376168
Pfizer
Completed
A Phase III Trial to Assess the Safety and Efficacy of Plant Cell Expressed GCD in Patients With Gaucher Disease

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