WHO ICTRP trial

A Long-Term, Open-Label, Safety and Efficacy Study of Cysteamine Bitartrate…

NL-OMON44053 · Overview of Medical Research in the Netherlands (NL-OMON) · Not Recruiting

Key facts

Trial ID NL-OMON44053
Public title A Long-Term, Open-Label, Safety and Efficacy Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Patients with Cystinosis.
Scientific title A Long-Term, Open-Label, Safety and Efficacy Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Patients with Cystinosis. - RP103-04
Primary sponsor Raptor Pharmaceuticals Europe BV
Registry Overview of Medical Research in the Netherlands (NL-OMON)
Recruitment status Not Recruiting
Study type Interventional
Phase 3
Countries The Netherlands
Conditions Nephropathic cystinosis; metabolic disorder in which the transport of cystine out of the lysosomes is abnormal;10000546;Nephropathic cystinosis; metabolic disorder in which the transport of cystine out of the lysosomes is abnormal
Interventions This is an open-label study during which patients will receive RP103 for up to 8 years. ;Cysteamine Bitartrate (INN : mercaptamine bitartrate) Delayed-release Capsules;Long-term;Nephropathic Cystinosis;Open-label
Registration date Jan 21, 2016
Target size 5
Secondary IDs 2010-018365-34;NCT01197378;NL33066.091.10
Registry page onderzoekmetmensen.nl

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