Evaluation of the Quality of Life in Patients With Chronic Iron Overload Due to Hemoglobinopathie… (NCT07352878) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluation of the Quality of Life in Patients With Chronic Iron Overload Due to Hemoglobinopathies in Greece.
150 participantsStarted 2026-04-15
Plain-language summary
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.
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion Criteria:
* 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).
3\. Patients with chronic iron overload due to blood transfusions if deferoxamine therapy is contraindicated or insufficient in the following patient groups:
* 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.
4\. Patients with non-transfusion-dependent thalassemia syndromes with chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or insufficient.
5\. Patients 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.
6\. Consent and compliance of participants with the treatments and procedures of the study.
7\. Patients for whom data from the last six months from the date of inclusion (medical history, concomitant medication) are available to determine the endpoints.
Exclusion Criteria:
* 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.
4\. Patients receiving…
What they're measuring
1
Assessment of health-related quality of life in patients with chronic iron overload
Timeframe: Score of the Short-Form 36-item Health Survey (SF-36v2) questionnaire at baseline, at 6 and at 12 months and the change from baseline and among at 6 and 12 months