An Open-Label, Safety and Effectiveness Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Cysteamine Treatment Naïve Patients With Cystinosis

Trial Profile

An Open-Label, Safety and Effectiveness Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Cysteamine Treatment Naïve Patients With Cystinosis

Completed
Phase of Trial: Phase III

Latest Information Update: 19 Jan 2018

At a glance

  • Drugs Mercaptamine bitartrate (Primary)
  • Indications Cystinosis
  • Focus Pharmacodynamics; Registrational
  • Sponsors Horizon Pharma USA; Raptor Pharmaceutical Inc
  • Most Recent Events

    • 27 Dec 2017 According to a Horizon Pharma media release, based on the results of this trial, the US FDA has approved an expansion to the indication for PROCYSBI (cysteamine bitartrate) delayed-release capsules to include children one year of age and older living with nephropathic cystinosis.
    • 27 Dec 2017 Results presented in a Horizon Pharma media release.
    • 13 Feb 2017 Status changed from active, no longer recruiting to completed.
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