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

Completed · Phase 2

Conditions studied: Iron Overload Due to Repeated Red Blood Cell Transfusions

In brief

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

Key facts

Study ID: NCT03802916
Run by: ApoPharma
People needed: 30
Starts: 2019-03-06
Expected to finish: 2019-12-19
Last updated by the study team: 2021-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female aged ≥ 18 years.
Diagnosis of thalassemia syndrome, sickle cell disease, or other disorder requiring a regular regimen of red blood cell transfusions.
On a stable regimen (≥3 months) of Ferriprox tablets for the treatment of systemic iron overload.
Absolute neutrophil count ≥1.5 x 10\^9/L at screening.
A record of at least 12 measured alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels.

You may not qualify if…

Receipt of any iron chelator other than Ferriprox (i.e., combination therapy) in the last 3 months, or planning to receive it at any time during the period of the study.
ALT and/or AST value > 5 times the upper limit of normal (ULN) at screening
Active case of hepatitis B or C at screening.

Where it is running

Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
New York Presbyterian Hospital/Weill Cornell Medical Center — New York, New York, United States
St.Paul's Hospital — Vancouver, British Columbia, Canada
National and Kapodistrian University of Athens, Aghia Sophia Children's Hospital — Goudi, Athens, Greece
San Luigi Gonzaga University Hospital Reparto Microcitemie-Pediatria — Orbassano (TO), Regione Gonzole, Italy

Full record on ClinicalTrials.gov

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