CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 435 enrolled
Drug / intervention
Deferiprone +1 moredrug
Likely dose
Deferiprone 80 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/NCT01825512
NCT01825512Phase 3Completed
CompareCT.gov

Multicentre, Randomised, Open Label, Non-inferiority Trial to Evaluate the Efficacy and Safety of Deferiprone Compared to Deferasirox in Patients Aged From 1 Month to Less Than 18 Years Affected by Transfusion Dependent Haemoglobinopathies

Consorzio per Valutazioni Biologiche e Farmacologiche·interventional·Posted Apr 5, 2013·Updated May 4, 2021

In Brief

A Phase 3 clinical trial evaluating Deferiprone and Deferasirox for Chronic Iron Overload. Completed, enrolled 435 participants across 22 sites in 7 countries.

Detailed Summary

Multicentre, randomised, open label, non-inferiority active-controlled trial to evaluate efficacy and safety of a 12-months treatment with deferiprone (DFP) at dose of 75-100 mg/kg/day versus deferasirox (DFX) at dose of 20-40 mg/kg/day in paediatric patients (1 month \< 18 years old) affected by hereditary haemoglobinopathies and requiring frequent transfusions and chelation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Iron Overload
CountriesAlbania, Cyprus, Egypt, Greece, Italy, Tunisia, United Kingdom
CollaboratorsEuropean Commission

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 5, 2013
Enrollment StartMar 17, 2014
Primary CompletionSep 21, 2017
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 13.2 years ago

Interventions

Deferipronedrug

Deferiprone 80 mg/mL oral solution

Deferasiroxdrug

Deferasirox is used at the following dosage strengths: 125 mg, 250 mg and 500 mg