NCT03802916

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: ApoPharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Iron Overload Due to Repeated Red Blood Cell Transfusions

Interventions

Type	Name	Description
DRUG	Deferiprone DR tablets 1000 mg (Low dosage)	Deferiprone DR tablets 1000 mg
DRUG	Deferiprone DR tablets 1000 mg (High dosage)	Deferiprone DR tablets 1000 mg

Timeline

• Start date: 2019-03-06
• Primary completion: 2019-12-04
• Completion: 2019-12-19
• First posted: 2019-01-14
• Last updated: 2021-07-16
• Results posted: 2021-06-18

Locations

5 sites across 4 countries: United States, Canada, Greece, Italy

Regulatory

• FDA-regulated drug study