A study looking at the safety and tolerability of a new formulation of deferiprone inpatients with excess iron due to frequent blood transfusions
Phase 1
- Conditions
- Systemic iron overloadMedDRA version: 20.0Level: PTClassification code 10065973Term: Iron overloadSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2018-004016-22-GR
- Lead Sponsor
- ApoPharma Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
•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
•A record of at least the last 12 measured ALT and AST levels prior to baseline
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Exclusion Criteria
•ALT and/or AST value > 5 x ULN at screening
•Active case of hepatitis B or C at screening
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method