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NCT01000961 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study of Cysteamine Bitartrate Delayed-release (RP103) Compared to Cystagon® in Patients With Cystinosis
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 43
- Enrollment target
NCT01000961: Completed Phase 3 study, sponsored by Amgen.
NCT01000961 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 43 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01000961, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 43 participants
- Enrollment target
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) 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 to four times a day Cystagon®.
Interventions
- DRUG Cystagon® (Cysteamine Bitartrate)
- DRUG Cysteamine Bitartrate Delayed-release Capsules (RP103)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2010-06 |
| Est. Completion | 2011-08 |
| Phase | Phase 3 |
What the finished NCT01000961 record still lists
NCT01000961 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Cystagon® (Cysteamine Bitartrate) is the first listed.
NCT01000961 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01000961 about?
NCT01000961 is a clinical study titled "Phase 3 Study of Cysteamine Bitartrate Delayed-release (RP103) Compared to Cystagon® in Patients With Cystinosis". 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) which must be taken every six hours for the rest of the patient's life to prevent complications of cystinosis. RP103...
What is the current status of trial NCT01000961?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 43 participants. The study started on 2010-06. Estimated completion is 2011-08.
What interventions are being tested in trial NCT01000961?
The interventions under investigation include: Cystagon® (Cysteamine Bitartrate) (DRUG), Cysteamine Bitartrate Delayed-release Capsules (RP103) (DRUG).
Who is sponsoring clinical trial NCT01000961?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01000961's enrollment target sits among peer trials
43 1876th of 2000 higher than 124 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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