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NCT01744782 · ClinicalTrials.gov registry record · Phase 3
Safety/Effectiveness Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Cysteamine Treatment Naive Patients With Cystinosis
A Phase 3 study of Cystinosis, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 17
- Enrollment target
- 2
- Study locations
NCT01744782: Completed Phase 3 study of Cystinosis, sponsored by Amgen.
NCT01744782 is a Phase 3 study of Cystinosis that has completed, run by Amgen. The registered enrollment target is 17 participants, below the 201-participant average among 4 other Cystinosis trials with a reported enrollment target (92% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01744782, a Phase 3 study of Cystinosis, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 17 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Primary Outcome
Blood samples were taken 30 minutes after the morning RP103 dose at each study visit to determine White Blood Cell (WBC) cystine concentration. WBC cystine concentrations were determined using liquid chromatography.
Conditions Studied
Interventions
- DRUG RP103
Study Locations (2)
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
São Paulo
- Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo - São Paulo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2012-12-20 |
| Est. Completion | 2016-12-13 |
| Phase | Phase 3 |
What the finished NCT01744782 record still lists
NCT01744782 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 201-participant average among 4 other Cystinosis trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Cystinosis appearing as the primary indexed condition, and to 1 intervention - of which RP103 is the first listed.
NCT01744782 reports a single indexed study location in Illinois, São Paulo.
Frequently Asked Questions
What is clinical trial NCT01744782 about?
NCT01744782 is a clinical study titled "Safety/Effectiveness Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Cysteamine Treatment Naive Patients With Cystinosis". 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 PROC...
What is the current status of trial NCT01744782?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 17 participants. The study started on 2012-12-20. Estimated completion is 2016-12-13.
What conditions does trial NCT01744782 study?
This clinical trial studies the following conditions: Cystinosis.
What interventions are being tested in trial NCT01744782?
The interventions under investigation include: RP103 (DRUG).
Who is sponsoring clinical trial NCT01744782?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01744782 being conducted?
This trial has 2 study locations across Illinois, São Paulo. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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