CompletedPhase 2

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

United States, Canada, Greece30 participantsStarted 2019-03-06

Plain-language summary

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

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

The Percentage of Patients in Each Treatment Group Who Experience Post-dose Increases in Liver Enzyme Levels That Are Considered a Safety Concern.

Timeframe: Day 28

NCT IDNCT03802916

SponsorApoPharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-12-04

Results submitted2021-03-01