Status:
COMPLETED
Safety and Acceptability of Deferiprone Delayed Release Tablets in Patients With Systemic Iron Overload
Lead Sponsor:
ApoPharma
Conditions:
Iron Overload Due to Repeated Red Blood Cell Transfusions
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 takin...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03802916
Start Date
March 6 2019
End Date
December 19 2019
Last Update
July 16 2021
Active Locations (5)
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1
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
2
New York Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, United States, 10065
3
St.Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
4
National and Kapodistrian University of Athens, Aghia Sophia Children's Hospital
Goudi, Athens, Greece, 11527