At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 40 enrolled

Drug / intervention

Deferasiroxdrug

Likely dose

Deferasirox 10 mg/kgfrom 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/NCT00390858

NCT00390858Phase 2Completed

Compare CT.gov

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.

Novartis Pharmaceuticals·interventional·Posted Oct 20, 2006·Updated Mar 20, 2017

In Brief

A Phase 2 clinical trial evaluating Deferasirox for Transfusional Iron Overload and 2 related conditions. Completed, enrolled 40 participants across 4 sites in 2 countries.

Detailed Summary

In this 4-year extension study the safety, efficacy and and pharmacokinetics of deferasirox in regularly transfused pediatric patients with β-thalassemia major was assessed. Patients who successfully completed the main 1 year trial (NCT00390858) were eligible to continue in this extension trial and receive chelation therapy with deferasirox for up to 4 years.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsTransfusional Iron Overload, β-thalassemia Major, Pediatric Rare Anemia

CountriesFrance, Italy

Collaborators--

Timeline

Phase 2CompletedFinished

200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartSep 2003

First PostedOct 2006

Primary CompletionFeb 2008

TodayJul 2026

First PostedOct 20, 2006

Enrollment StartSep 1, 2003

Primary CompletionFeb 1, 2008

TodayJul 2, 2026

Enrollment to primary: 4.4 yearsPosted 19.7 years ago

Interventions

Deferasiroxdrug

Deferasirox in children from 1 to 18 years old was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters and on increasing or decreasing Liver Iron Concentration (LIC), and serum ferritin. Deferasirox was available as 125 mg, 250 mg and 500 mg tablets.