At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pilot Pharmacokinetic Study In Patients With Inadequate Response To Deferasirox (Exjade)
In Brief
A Phase 4 clinical trial evaluating Deferoxamine, Deferasirox, and 1 other intervention for Transfusion-dependent Hemachromatosis and 2 related conditions. Completed, enrolled 15 participants across 1 site.
Detailed Summary
This purpose of this study is to understand the differences between people who have a good response to deferasirox (exjade) compared to people who have a poor response to this medication when used for transfusion-dependent iron overload. The hypothesis is that patients with poor responses have physiologic barriers to deferasirox that may include absorption, pharmacokinetics of drug metabolism, hepatic clearance and/or genetic factors.
Study Details
Timeline
Interventions
After a 3-day washout period from all chelation, all patients have a 12 hour infusion of 50mg/kg of deferoxamine with urine collection and pre and post blood sampling to assess iron and Total Iron Binding Capacity (TIBC) by atomic absorption.
After a 3-day washout period from all chelation, patients had a desferal challenge which was followed by a single dose of deferasirox, 35mg/kg orally with blood sampling taken pre-deferasirox and at intervals for 24 hours after the dose.
All patients had a HIDA scan to assess physiologic liver clearance capacity.