About this trial
This observational clinical study aims to evaluate the HRQoL of thalassemia patients with iron overload in Greece, who are under treatment with deferasirox based on standard clinical practice.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Adult patients (≥ 18 years). 2. Patients with major beta-thalassemia with iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells).
adult patients with major beta-thalassemia with iron overload due to infrequent blood transfusions (<7 ml/kg/month of packed red blood cells).
adult patients with other types of anemia.
Disqualifiers
1. Patients under 18 years of age. 2. Patients with myelodysplastic syndromes. 3. Patients with a contraindication to taking deferasirox 90, 180, 360, 900 mg according to the drug's SmPC.
Trial population
Adult patients with major beta-thalassemia with iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) will be included in the study and who were receiving deferasirox before their inclusion in the study (90, 180, 360, 900 mg) and at their inclusion require treatment with deferasirox at least 900 mg, as part of the treatment of chronic iron overload and according to the SPC.
Trial design
Other
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Assessment of health-related quality of life in patients with chronic iron overload
Score of the Short-Form 36-item Health Survey (SF-36v2) questionnaire
Locations
Sponsors and contacts
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Elpen Pharmaceutical Co. Inc.
Lead sponsor
Aghia Sophia Children's Hospital of Athens
Collaborator
This trial is not recruiting at the moment. You can still explore other options: