An observational study in Thalassemia and Iron Overload, sponsored by Elpen Pharmaceutical Co. Inc.. Not yet recruiting. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by Elpen Pharmaceutical Co. Inc. · Observational
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.
The assessment of health-related quality of life (HRQoL) in thalassemic patients with iron overload offers a holistic approach to the disease and leads to better communication between physicians and patients. This prospective, non-interventional, observational clinical study aims to evaluate the HRQoL, adherence to deferasirox treatment and treatment effectiveness as well as patients' satisfaction and safety with deferasirox.
All participants will complete a set of questionnaires and scales for QoL, adherence to treatment, and satisfaction of the treatment for iron overload. Demographic and clinical characteristics will be recorded to define patient subgroups based on the study protocol.
250 studies on the registry are indexed under Thalassemia; 43 are open to participants now.
This study's planned enrollment of 150 is above the median of 106 across 70 observational studies indexed under Thalassemia.
Browse Thalassemia studies →Elpen Pharmaceutical Co. Inc. is the lead sponsor of 45 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 or insufficient in the following patient groups:
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 to taking deferasirox 90, 180, 360, 900 mg according to the drug's SmPC.
4. Patients receiving or expect to receive another chelating agent (e.g. deferoxamine, deferiprone) in addition to deferasirox, during the study.
5. Patients with a history of mental illness, substance abuse, to a degree that may prevent their participation in the study.
6. Patients are participating in another research protocol.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
No study locations are listed for this record.
Plan to share: No
Start is estimated for Apr 2026; primary completion for Dec 2027, 20 months later.
Of 23 observational studies under Thalassemia, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 74. This study's planned 20 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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