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A Safety and Efficacy Study of Two Dose Levels of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease

Last updated on March 15, 2019

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Study Location
Shaare Zedek Medical Center
Jerusalem, , Israel
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
2-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Males and females 2 to

- Diagnosis of Gaucher disease with leukocyte acid β-glucosidase activity ≤30% of the
mean of the reference range for healthy subjects.

- Subjects who have not received enzyme replacement therapy (ERT) in the past or who
have not received ERT in the past 12 months and have a negative
anti-glucocerebrosidase antibody assay.

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

- Subjects whose clinical condition, in the opinion of the investigator, requires
treatment with enzyme replacement therapy (ERT).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Currently taking another investigational drug for any condition.

- Presence of neurological signs and symptoms characteristic of Gaucher disease with
complex neuronopathic features other than longstanding oculomotor gaze palsy.

- Presence of unresolved anemia due to iron, folic acid, or vitamin B12 deficiency

- Previous hypersensitivity reaction to Cerezyme® (imiglucerase) or Ceredase®
(alglucerase).

- History of allergy to carrots.

- Presence of HIV, HBsAg or hepatitis C infections.

- Subject's parent(s) or legal guardian(s) are unable to understand the nature, scope
and possible consequences of the study.

- Presence of any medical, emotional, behavioral or psychological condition that in the
judgment of the Investigator would interfere with the subject's compliance with the
requirements of the study.

NCT01132690
Pfizer
Completed
A Safety and Efficacy Study of Two Dose Levels of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease

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