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NCT01197378 · ClinicalTrials.gov registry record · Phase 3
Long-Term Safety Follow-up Study of Cysteamine Bitartrate Delayed-release Capsules (RP103)
A Phase 3 study of Cystinosis, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 60
- Enrollment target
- 10
- Study locations
NCT01197378: Completed Phase 3 study of Cystinosis, sponsored by Amgen.
NCT01197378 is a Phase 3 study of Cystinosis that has completed, run by Amgen. The registered enrollment target is 60 participants, below the 190-participant average among 4 other Cystinosis trials with a reported enrollment target (68% lower). The trial reports 10 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01197378, a Phase 3 study of Cystinosis, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 60 participants
- Enrollment target
- 10
- Study locations
Study Summary
Cystinosis is an inherited disease that if untreated, results in kidney failure as early as the first decade of life. The current marketed therapy is Cystagon® (cysteamine bitartrate immediate release) which must be taken every six hours for the rest of the patient's life to prevent complications of cystinosis. Cysteamine bitartrate delayed-release capsules (RP103) is a formulation of cysteamine bitartrate that is being studied to see if it can be given less frequently, once every 12 hours, and have similar results to four times a day Cystagon®.
Primary Outcome
Drug-related adverse events (AEs) are AEs the investigator assessed as having relation to drug of 'possibly', 'probably' or 'definitely'. The severity of AEs was categorized according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 as follows: * Mild (Grade 1): experience is minor and does not cause significant discomfort to subject or change in activities of daily living (ADL); subject is aware of symptoms but symptoms are easily tolerated; * Moderate (Grade 2): exp
Conditions Studied
Interventions
- DRUG Cysteamine Bitartrate Delayed-release Capsules
Study Locations (10)
Other
- Hospices Civils de Lyon - Lyon
- Hôpital Arnaud Villeneuve - CHU Montpellier - Montpellier
- Hopital Necker - Paris
- Robert Debre Hospital - Paris
- Radboud University Nijmegen Medical Center - Nijmegen
California
- California Pacific Medical Center (CPMC) Research Institute - San Francisco
- Stanford University Medical School - Stanford
Georgia
- Emory Children's Center - Atlanta
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Texas
- Texas Children's Hospital/Baylor University - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2010-08-27 |
| Est. Completion | 2017-06-26 |
| Phase | Phase 3 |
What the finished NCT01197378 record still lists
NCT01197378 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 190-participant average among 4 other Cystinosis trials with a reported enrollment target (68% lower).
The record links to 1 condition, with Cystinosis appearing as the primary indexed condition, and to 1 intervention - of which Cysteamine Bitartrate Delayed-release Capsules is the first listed.
NCT01197378 lists 10 locations in 5 states (Other, California, Georgia).
Frequently Asked Questions
What is clinical trial NCT01197378 about?
NCT01197378 is a clinical study titled "Long-Term Safety Follow-up Study of Cysteamine Bitartrate Delayed-release Capsules (RP103)". Cystinosis is an inherited disease that if untreated, results in kidney failure as early as the first decade of life. The current marketed therapy is Cystagon® (cysteamine bitartrate immediate release) which must be taken every six hours for the rest of the patient's life to prevent complications of...
What is the current status of trial NCT01197378?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 60 participants. The study started on 2010-08-27. Estimated completion is 2017-06-26.
What conditions does trial NCT01197378 study?
This clinical trial studies the following conditions: Cystinosis.
What interventions are being tested in trial NCT01197378?
The interventions under investigation include: Cysteamine Bitartrate Delayed-release Capsules (DRUG).
Who is sponsoring clinical trial NCT01197378?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01197378 being conducted?
This trial has 10 study locations across California, Georgia, Illinois, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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