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

• Status: Completed
• Trial end date: 2019-12-19
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ApoPharma
• Treatments: Deferiprone

Criteria

Inclusion Criteria:

1. Male or female aged ≥ 18 years.

2. Diagnosis of thalassemia syndrome, sickle cell disease, or other disorder requiring a regular regimen of red blood cell transfusions.

3. On a stable regimen (≥3 months) of Ferriprox tablets for the treatment of systemic iron overload.

4. Absolute neutrophil count ≥1.5 x 10^9/L at screening.

5. A record of at least 12 measured alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels.

Exclusion Criteria:

1. 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.

2. ALT and/or AST value > 5 times the upper limit of normal (ULN) at screening

3. Active case of hepatitis B or C at screening.