Evaluation of the Quality of Life in Patients With Chronic Iron Overload Due to Hemoglobinopathies in Greece.

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorElpen Pharmaceutical Co. Inc.

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Elpen Pharmaceutical Co. Inc.

Lead sponsor

Aghia Sophia Children's Hospital of Athens

Collaborator

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