CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 44 enrolled
Drug / intervention
Deferasiroxdrug
Likely dose
Deferasirox 360mgfrom 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/NCT03372083
NCT03372083Phase 4Completed
CompareCT.gov

A Single-arm Interventional Phase IV, Post-authorisation Study Evaluating the Safety of Pediatric Patients With Transfusional Hemosiderosis Treated With Deferasirox Crushed Film Coated Tablets

Novartis Pharmaceuticals·interventional·Posted Dec 13, 2017·Updated Aug 25, 2020

In Brief

A Phase 4 clinical trial evaluating Deferasirox for Iron Overload. Completed, enrolled 44 participants across 10 sites in 7 countries.

Detailed Summary

This study employed a prospective, single-arm, global multi-center interventional open-label, non-randomized design to identify and assess safety profile of the crushed deferasirox FCT when administered up to 24 weeks in pediatric patients aged ≥2 to \<6 years with transfusional hemosiderosis. The study was designed to enroll a minimum of 40 patients. Forty-four patients were treated and analyzed.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIron Overload
CountriesEgypt, Italy, Lebanon, Oman, Thailand, United Arab Emirates, United Kingdom
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedDec 13, 2017
Enrollment StartJan 16, 2018
Primary CompletionDec 5, 2019
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 8.6 years ago

Interventions

Deferasiroxdrug

Deferosirox was provided in tablet forms of 90, 180 and 360mg. Tablets were crushed in the home environment and administered by sprinkling the full dose on to soft food to be consumed immediately.