Long-Term Safety Follow-up Study of Cysteamine Bitartrate Delayed-release Capsules (RP103)
Status:
Completed
Trial end date:
2017-06-26
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
immediate release) which must be taken every six hours for the rest of the patient's life to
prevent complications of cystinosis. Cysteamine bitartrate delayed-release capsules (RP103)
is a formulation of cysteamine bitartrate that is being studied to see if it can 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.