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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01744782
The ClinicalTrials.gov registry entry for NCT01744782 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 201-participant average among 4 other Cystinosis trials with a reported enrollment target (92% lower). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
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