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NCT00872729 · ClinicalTrials.gov registry record · Phase 1
Pilot Study of Safety, Tolerability, Pharmacokinetics/Pharmacodynamics of RP103 Compared to Cystagon® in Patients With Cystinosis
A Phase 1 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT00872729 is a Phase 1 study that has completed, run by Amgen. The registered enrollment target is 9 participants.
The verdict
NCT00872729, a Phase 1 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
Cystinosis is an inheritable disease that if untreated, results in kidney failure as early as the first decade of life. The current marketed therapy is Cystagon® (cysteamine bitartrate) which must be taken every six hours for the rest of the patient's life to prevent complications of cystinosis. RP103 is a formulation of cysteamine bitartrate that is being studied to see if it may be able to be given less frequently, once every 12 hours, and have similar results.
Interventions
- DRUG RP103
- DRUG Cystagon®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2009-05 |
| Est. Completion | 2009-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00872729
The ClinicalTrials.gov registry entry for NCT00872729 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which RP103 is the first listed.
NCT00872729 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00872729 about?
NCT00872729 is a clinical study titled "Pilot Study of Safety, Tolerability, Pharmacokinetics/Pharmacodynamics of RP103 Compared to Cystagon® in Patients With Cystinosis". Cystinosis is an inheritable disease that if untreated, results in kidney failure as early as the first decade of life. The current marketed therapy is Cystagon® (cysteamine bitartrate) which must be taken every six hours for the rest of the patient's life to prevent complications of cystinosis. RP1...
What is the current status of trial NCT00872729?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2009-05. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00872729?
The interventions under investigation include: RP103 (DRUG), Cystagon® (DRUG).
Who is sponsoring clinical trial NCT00872729?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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