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Long-Term Safety Follow-up Study of Cysteamine Bitartrate Delayed-release Capsules (RP103)
NCT01197378 · View on ClinicalTrials.gov ↗
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®.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01197378
The ClinicalTrials.gov registry entry for NCT01197378 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 266 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01197378 reports 10 study locations spanning 5 distinct geographic areas — top geographies include Other, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01197378?
The interventions under investigation include: Cysteamine Bitartrate Delayed-release Capsules (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01197378?
This trial is sponsored by Amgen, which has 266 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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