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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 is a Phase 4 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 24 participants.
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.
Interventions
- DRUG Deferasirox
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2005-09 |
| Est. Completion | 2008-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00117507
The ClinicalTrials.gov registry entry for NCT00117507 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Deferasirox is the first listed.
NCT00117507 reports 0 study locations.
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.
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