Safety and Acceptability of Deferiprone Delayed Release Tablets in Patients With Systemic Iron Overload — TWICE

Iron Overload Due to Repeated Red Blood Cell Transfusions Clinical Trial

Official title:
Safety and Acceptability of Deferiprone Delayed Release Tablets in Patients With Systemic Iron Overload

Status Completed

Clinical Trial Summary

Safety, tolerability, and acceptability of twice-daily dosing with deferiprone delayed-release (DR) tablets in patients with systemic iron overload.

Clinical Trial Description

This study is looking at the safety, tolerability, and acceptability of twice-daily dosing with deferiprone delayed-release (DR) tablets in patients with systemic iron overload who are currently taking deferiprone immediate-release tablets (Ferriprox) three times a day. Ferriprox doses range from 75 milligrams per kilogram of body weight (mg/kg) per day to 100 mg/kg per day. Half the patients in the study will be on a dosage that is closer to the low end of the range, and half will be on a dosage that is closer to the high end. Both groups will be switched for one month to deferiprone DR tablets at approximately the same total daily dosage that they have been taking for Ferriprox. ;

Study Design

Related Conditions & MeSH terms

Iron Overload
Iron Overload Due to Repeated Red Blood Cell Transfusions

Clinical Trial Details

NCT number	NCT03802916
Study type	Interventional
Source	Chiesi Canada Corp
Contact
Status	Completed
Phase	Phase 2
Start date	March 6, 2019
Completion date	December 19, 2019

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT01604941` - Pharmacokinetics of SSP-004184 in the Treatment of Chronic Iron Overload Requiring Chelation Therapy	Phase 2
Completed	`NCT02477631` - Effect of Deferiprone on Oxidative-Stress and Iron-Overload in Low Risk Transfusion-Dependent MDS Patients	Phase 2
Terminated	`NCT01671111` - Study for Transfusionally Iron Overloaded Children, Adolescents and Adults Using FBS0701 (SSP-004184)	Phase 2