26
Participants
Start Date
June 30, 2006
Primary Completion Date
August 31, 2009
Study Completion Date
December 31, 2015
Eliglustat tartrate
Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg twice daily (BID) from Day 2 to Day 19, then either eliglustat 50 mg BID (if Genz-99067\[active moiety of eliglustat in plasma\] trough plasma concentration was greater than or equal to \[\>=\]5 nanogram per milliliter \[ng/mL\] on Day 10) or eliglustat 100 mg BID(if Genz-99067 trough plasma concentration was less than \[\<\] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing same treatment through study completion (Year 9). Participant receiving 100 mg BID could be considered for further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
New York University, New York
New York
Aprillus Asistencia e Investigación, Buenos Aires
Hospital de Oncologia Maria Curie, Buenos Aires
Hospital Ramos Mejia, Buenos Aires
IMAI, Buenos Aires
Instituto Argentino de Diagnostico y Tratamiento (IADT), Buenos Aires
Buenos Aires
Rambam Medical Center, Haifa
Haifa
Sha'are Zedek Medical Centre, Jerusalem
Jerusalem
Universita degli Studi di Milano, Milan
Instituto Mexicano del Seguro Social, D.f.
Mexico City
Hematology Research Center of Ministry of Healthcare of the Russian Federation, Moscow
Moscow
Genzyme, a Sanofi Company
INDUSTRY