Phase 3 Study of Cysteamine Bitartrate Delayed-release (RP103) Compared to Cystagon® in Patients With Cystinosis
Status:
Completed
Trial end date:
2011-08-01
Target enrollment:
Participant gender:
Summary
Cystinosis is an inherited disease that if untreated, results in kidney failure as early as
the first decade of life. The current marketed therapy is Cystagon® (cysteamine bitartrate)
which must be taken every six hours for the rest of the patient's life to prevent
complications of cystinosis. RP103 is a formulation of cysteamine bitartrate that is being
studied to see if it may be able to be given less frequently, once every 12 hours, and have
similar results to four times a day Cystagon®.
Phase:
Phase 3
Details
Lead Sponsor:
Horizon Pharma USA, Inc. Raptor Pharmaceuticals Inc.