WHO ICTRP trial

A Study of Genz-112638 in Patients With Gaucher Disease (ENGAGE)

CTRI/2009/091/000689 · Clinical Trials Registry India (CTRI) · Not Recruiting

Key facts

Trial ID CTRI/2009/091/000689
Public title A Study of Genz-112638 in Patients With Gaucher Disease (ENGAGE)
Scientific title A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Confirming the Efficacy and Safety of Genz-112638 in Patients With Gaucher Disease Type 1 - ENGAGE
Primary sponsor Genzyme Europe BV
Registry Clinical Trials Registry India (CTRI)
Recruitment status Not Recruiting
Study type Interventional
Phase Phase 3
Countries India;Bulgaria;Canada;Chile;Colombia;India;Israel;Jordan;Lebanon;Mexico;Netherlands;Russian Federation;Saudi Arabia;Tunisia;United Kingdom;United States of America
Conditions Health Condition 1: null- Gaucher Disease Type 1 Health Condition 2: E752- Other sphingolipidosis
Interventions Intervention1: Genz-112638: Capsule: 50, 100 or 150 mg BID Control Intervention1: Placebo: Capsule
Registration date Dec 10, 2009
Target size 28
Secondary IDs 2008-005222-37;GZGD02507;NCT00891202
Registry page ctri.nic.in

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