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NCT00117507 · ClinicalTrials.gov registry record · Phase 4
Study for the Treatment of Transfusional Iron Overload in Myelodysplastic Patients
A Phase 4 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 24
- Enrollment target
NCT00117507: Completed Phase 4 study, sponsored by Novartis Pharmaceuticals.
NCT00117507 is a Phase 4 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 24 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00117507, a Phase 4 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 24 participants
- Enrollment target
Study Summary
Thirty patients were to be enrolled and 24 patients were actually enrolled into this open-label, single-arm trial designed to assess the safety and tolerability of oral deferasirox in adult transfusion dependent myelodysplastic syndrome (MDS) patients with iron overload. Patients enrolled in this study had low or intermediate (INT-1) risk MDS per International Prognostic Scoring System (IPSS) criteria. All patients initiated treatment with 20mg/kg/day deferasirox. Deferasirox were administered orally once per day for 12 months.
Primary Outcome
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. Any sign or symptom that occured from first dose of study treatment until end of study treatment.
Interventions
- DRUG Deferasirox
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2005-09 |
| Est. Completion | 2008-01 |
| Phase | Phase 4 |
What the finished NCT00117507 record still lists
NCT00117507 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Deferasirox is the first listed.
NCT00117507 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00117507 about?
NCT00117507 is a clinical study titled "Study for the Treatment of Transfusional Iron Overload in Myelodysplastic Patients". Thirty patients were to be enrolled and 24 patients were actually enrolled into this open-label, single-arm trial designed to assess the safety and tolerability of oral deferasirox in adult transfusion dependent myelodysplastic syndrome (MDS) patients with iron overload. Patients enrolled in this st...
What is the current status of trial NCT00117507?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 24 participants. The study started on 2005-09. Estimated completion is 2008-01.
What interventions are being tested in trial NCT00117507?
The interventions under investigation include: Deferasirox (DRUG).
Who is sponsoring clinical trial NCT00117507?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00117507's enrollment target sits among peer trials
24 1699th of 2000 higher than 276 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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