CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 184 enrolled
Drug / intervention
Deferasiroxdrug
Likely dose
Deferasirox 125 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00303329
NCT00303329Phase 2Completed
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Extension Study of Iron Chelation Therapy With Deferasirox in β-thalassemia and Other Patients With Rare Chronic Anemia and Transfusional Iron Overload

Novartis Pharmaceuticals·interventional·Posted Mar 16, 2006·Updated May 9, 2011

In Brief

A Phase 2 clinical trial evaluating Deferasirox for Anemia and Hemosiderosis. Completed, enrolled 184 participants across 28 sites in 7 countries.

Detailed Summary

A 1-year randomized Phase II core trial was conducted to investigate the efficacy of deferasirox in regularly transfused patients with β-thalassemia and other rare chronic anemia 2 years of age and older. Patients who successfully completed the main trial may continue in the extension trial to receive chelation therapy with deferasirox for up to 3 years. Extension was prolonged to 4 years. The objective of this study is to assess the long-term safety and efficacy of deferasirox in these patient groups.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia, Hemosiderosis
CountriesBelgium, Canada, France, Germany, Italy, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 16, 2006
Enrollment StartMar 1, 2004
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 20.3 years ago

Interventions

Deferasiroxdrug

Deferasirox available as 125 mg, 250 mg or 500 mg tablets