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



Status:Archived
Conditions:Metabolic
Therapuetic Areas:Pharmacology / Toxicology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:August 2010
End Date:December 2011

Use our guide to learn which trials are right for you!

A Multicenter, Double-blind, Randomized Safety and Efficacy Study of Two Dose Levels of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease


This is a multi-center, double-blind trial to assess the safety and efficacy of
taliglucerase alfa in untreated subjects (2 to <18 years old) with Gaucher disease randomly
assigned to treatment with one of two doses, 30 or 60 units/kg. Subjects will receive an
intravenous (IV) infusion of taliglucerase alfa every two weeks. The total duration of
treatment will be 12 months. At the end of the 12-month treatment period eligible subjects
will be offered enrollment in an open-label extension study if taliglucerase alfa is not
commercially available.



We found this trial at
2
sites
New York, New York 10016
?
mi
from
New York, NY
Click here to add this to my saved trials
Springfield, Virginia 22152
?
mi
from
Springfield, VA
Click here to add this to my saved trials