A study of a drug (Ferriprox®) that removes extra iron from the body, to see how safe it is and how well it works in patients with sickle cell disease.
- Conditions
- Iron overload in sickle cell disease or other anemiasMedDRA version: 20.0 Level: SOC Classification code 10005329 Term: Blood and lymphatic system disorders System Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2014-005685-30-GB
- Lead Sponsor
- ApoPharma Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 300
Completed study LA38-0411.
Are the trial subjects under 18? yes
Number of subjects for this age range: 5
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
1. Plan to participate in another clinical trial at any time from the day of enrollment until 30 days post-treatment in the current study.
2. For only those patients who were treated with deferoxamine in study LA38-0411 (Group 2): Presence of any medical condition (including clinically significant laboratory abnormalities, such as ALT = 5 x ULN or creatinine = 2 x ULN), psychological condition, or psychiatric condition which in the opinion of the investigator would cause participation in the study to be unwise.
3. Pregnant, breastfeeding, or planning to become pregnant during the study period.
4. Treatment failure after 1 year on deferiprone which in the investigator’s judgment indicates the need for the patient to be started on a different iron chelator.
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