WHO ICTRP trial
A Long-Term, Open-Label, Safety and Efficacy Study of Cysteamine Bitartrate…
EUCTR2010-018365-34-FR · EU Clinical Trials Register
Key facts
| Trial ID | EUCTR2010-018365-34-FR |
|---|---|
| Public title | A Long-Term, Open-Label, Safety and Efficacy Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Patients with Nephropathic Cystinosis - RP103-04 |
| Scientific title | A Long-Term, Open-Label, Safety and Efficacy Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Patients with Nephropathic Cystinosis - RP103-04 |
| Primary sponsor | Raptor Therapeutics Inc. |
| Registry | EU Clinical Trials Register |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | France;Netherlands |
| Conditions | Cystinosis MedDRA version: 12.1 Level: LLT Classification code 10011777 Term: Cystinosis |
| Interventions | Product Name: Cysteamine bitartrate (INN: mercaptamine bitartrate ) Product Code: RP103 Pharmaceutical Form: Capsule, hard INN or Proposed INN: mercaptamine bitartrate CAS Number: CAS 27761-19 Current Sponsor code: RP103 Concentration unit… |
| Registration date | Jun 18, 2010 |
| Target size | 20 |
| Secondary IDs | RP103-04 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: