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CLINICAL TRIALS PROFILE FOR PROCYSBI

All Clinical Trials for PROCYSBI

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01744782 ↗	Safety/Effectiveness Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Cysteamine Treatment Naive Patients With Cystinosis	Completed	Horizon Pharma USA, Inc.	Phase 3	2012-12-20	This was a long-term, open-label study of the safety, tolerability and effectiveness of RP103 in cystinosis patients who were naïve to any form of cysteamine treatment. Participants received RP103 treatment for at least 12 months. U.S. participants transitioned to the commercially approved drug PROCYSBI®. In Brazil, after at least 12 months of study participation and upon approval by the Brazilian regulatory authorities, participants were eligible to transition to a post-study drug supply program, and continue to receive the drug at no personal cost.
NCT01744782 ↗	Safety/Effectiveness Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Cysteamine Treatment Naive Patients With Cystinosis	Completed	Raptor Pharmaceuticals Inc.	Phase 3	2012-12-20	This was a long-term, open-label study of the safety, tolerability and effectiveness of RP103 in cystinosis patients who were naïve to any form of cysteamine treatment. Participants received RP103 treatment for at least 12 months. U.S. participants transitioned to the commercially approved drug PROCYSBI®. In Brazil, after at least 12 months of study participation and upon approval by the Brazilian regulatory authorities, participants were eligible to transition to a post-study drug supply program, and continue to receive the drug at no personal cost.

Clinical Trial Conditions for PROCYSBI

Condition Name

Condition Name for PROCYSBI
Intervention	Trials
Cystinosis	1

Condition MeSH

Condition MeSH for PROCYSBI
Intervention	Trials
Cystinosis	1

Clinical Trial Locations for PROCYSBI

Trials by Country

Trials by Country for PROCYSBI
Location	Trials
Brazil	1
United States	1

Trials by US State

Trials by US State for PROCYSBI
Location	Trials
Illinois	1

Clinical Trial Progress for PROCYSBI

Clinical Trial Phase

Clinical Trial Phase for PROCYSBI
Clinical Trial Phase	Trials
Phase 3	1

Clinical Trial Status

Clinical Trial Status for PROCYSBI
Clinical Trial Phase	Trials
Completed	1

Clinical Trial Sponsors for PROCYSBI

Sponsor Name

Sponsor Name for PROCYSBI
Sponsor	Trials
Horizon Pharma USA, Inc.	1
Raptor Pharmaceuticals Inc.	1

Sponsor Type

Sponsor Type for PROCYSBI
Sponsor	Trials
Industry	2