CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 64 enrolled
Drug / intervention
Deferiprone oral solution +1 moredrug
Likely dose
Deferiprone oral solution 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/NCT03591575
NCT03591575Phase 4Completed
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Safety and Efficacy of Early-start Deferiprone Treatment in Infants and Young Children Newly Diagnosed With Transfusion-dependent Beta Thalassemia

Chiesi Canada Corp·interventional·Posted Jul 19, 2018·Updated Mar 15, 2024

In Brief

A Phase 4 clinical trial evaluating Deferiprone oral solution and Placebo for Beta Thalassemia Major Anemia and Iron Overload. Completed, enrolled 64 participants across 4 sites in 2 countries.

Detailed Summary

This study is looking at the effects of giving early treatment of deferiprone to young children with beta thalassemia who have started receiving regular blood transfusions but have not yet reached the criteria for starting on iron chelation therapy. Half the patients in the study will receive deferiprone, and the other half will receive placebo, for up to 12 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBeta Thalassemia Major Anemia, Iron Overload
CountriesEgypt, Indonesia
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedJul 19, 2018
Enrollment StartNov 9, 2018
Primary CompletionSep 29, 2020
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 8.0 years ago

Interventions

Deferiprone oral solutiondrug

Liquid formulation of deferiprone, with a concentration of 80 mg/mL

Placebodrug

Liquid solution that matches deferiprone oral solution in appearance and taste