Iron lowering treatment to reduce tissue damage in sickle cell disease
- Conditions
- Sickle cell disease (an hereditary hemoglobinopathy)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2020-004995-17-NL
- Lead Sponsor
- AMsterdam UMC-AMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 30
1. Sickle cell disease diagnosis: HbSS, or HbSß0-thalassemia genotype
2. Age 18-65 years
3. Willing and able to provide written informed consent
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
1. Blood transfusion in the preceding four months
2. Already using iron chelation due to iron overload
3. Ferritin levels of <50 µg/L and/or transferrin saturation of < 0.20.
4. LDH of < 300 U/L
5. Pregnancy or the desire to get pregnant in the following 6 months
6. Impaired renal function of GFR < 60 ml/min/1,73m2 (CKD-EPI).
7. Known allergic reaction to deferasirox.
8. Other somatic or cognitive condition disturbing adherence to study treatment
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