Clinical trial
A 4-year Extension Study to Core 1-year Study of Iron Chelation Therapy With…
NCT00390858 · Novartis Pharmaceuticals, Industry · Completed
Key facts
| NCT number | NCT00390858 |
|---|---|
| Title | A 4-year Extension Study to Core 1-year Study of Iron Chelation Therapy With Deferasirox in β-thalassemia Major Pediatric Patients With Transfusional Iron Overload. |
| Official title | A 4-year Extension to a Phase II a Multicenter Study Evaluating Long-term Safety, Tolerability, Pharmacokinetics and Effects on Liver Iron Concentration of Repeated Doses of 10 mg/kg/Day of Deferasirox in Pediatric Patients With Transfusion Dependent β-thalassemia Major. |
| Lead sponsor | Novartis Pharmaceuticals, Industry |
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Transfusional Iron Overload, β-thalassemia Major, Pediatric Rare Anemia |
| Intervention type | Drug |
| Interventions | Deferasirox |
| Enrollment | 40 |
| Start date | Sep 1, 2003 |
| Primary completion | Feb 1, 2008 |
| Completion | Feb 1, 2008 |
| First posted | Oct 20, 2006 |
| Last update posted | Mar 20, 2017 |
| Countries | France, Italy |
At a glance
- 1–9 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: