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

NCT07352878 | Not Yet Recruiting

• 1 other identifier: 2025-DEF-EL-256
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Thalassemia; Iron Overload

Keywords

quality of life; iron overload; treatment satisfaction

Outcome Measures

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

  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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• \. 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).
• \. 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.
• \. Patients with non-transfusion-dependent thalassemia syndromes with chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or insufficient.
• \. Consent and compliance of participants with the treatments and procedures of the study.

You may not qualify if:

• \. 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.
• \. Patients receiving or expect to receive another chelating agent (e.g. deferoxamine, deferiprone) in addition to deferasirox, during the study.
• \. Patients with a history of mental illness, substance abuse, to a degree that may prevent their participation in the study.
• \. Patients are participating in another research protocol.

Sponsors & Collaborators

• Elpen Pharmaceutical Co. Inc.: lead
• Aghia Sophia Children's Hospital of Athens: collaborator

Related Publications (7)

• Kattamis A, Aydinok Y, Taher A. Optimising management of deferasirox therapy for patients with transfusion-dependent thalassaemia and lower-risk myelodysplastic syndromes. Eur J Haematol. 2018 Sep;101(3):272-282. doi: 10.1111/ejh.13111. Epub 2018 Jul 27.

  PMID: 29904950 BACKGROUND

• Voskaridou E, Kattamis A, Fragodimitri C, Kourakli A, Chalkia P, Diamantidis M, Vlachaki E, Drosou M, Lafioniatis S, Maragkos K, Petropoulou F, Eftihiadis E, Economou M, Klironomos E, Koutsouka F, Nestora K, Tzoumari I, Papageorgiou O, Basileiadi A, Lafiatis I, Dimitriadou E, Kalpaka A, Kalkana C, Xanthopoulidis G, Adamopoulos I, Kaiafas P, Mpitzioni A, Goula A, Kontonis I, Alepi C, Anastasiadis A, Papadopoulou M, Maili P, Dionisopoulou D, Tsirka A, Makis A, Kostaridou S, Politou M, Papassotiriou I; Greek Haemoglobinopathies Study Group. National registry of hemoglobinopathies in Greece: updated demographics, current trends in affected births, and causes of mortality. Ann Hematol. 2019 Jan;98(1):55-66. doi: 10.1007/s00277-018-3493-4. Epub 2018 Sep 8.

  PMID: 30196444 BACKGROUND

• Arian M, Mirmohammadkhani M, Ghorbani R, Soleimani M. Health-related quality of life (HRQoL) in beta-thalassemia major (beta-TM) patients assessed by 36-item short form health survey (SF-36): a meta-analysis. Qual Life Res. 2019 Feb;28(2):321-334. doi: 10.1007/s11136-018-1986-1. Epub 2018 Sep 7.

  PMID: 30194626 BACKGROUND

• Tartaglione I, Origa R, Kattamis A, Pfeilstocker M, Gunes S, Crowe S, Fagan N, Vincenzi B, Ruffo GB. Two-year long safety and efficacy of deferasirox film-coated tablets in patients with thalassemia or lower/intermediate risk MDS: phase 3 results from a subset of patients previously treated with deferasirox in the ECLIPSE study. Exp Hematol Oncol. 2020 Aug 10;9:20. doi: 10.1186/s40164-020-00174-2. eCollection 2020.

  PMID: 32793403 BACKGROUND

• Goulas V, Kouraklis-Symeonidis A, Manousou K, Lazaris V, Pairas G, Katsaouni P, Verigou E, Labropoulou V, Pesli V, Kaiafas P, Papageorgiou U, Symeonidis A. A multicenter cross-sectional study of the quality of life and iron chelation treatment satisfaction of patients with transfusion-dependent beta-thalassemia, in routine care settings in Western Greece. Qual Life Res. 2021 Feb;30(2):467-477. doi: 10.1007/s11136-020-02634-y. Epub 2020 Sep 13.

  PMID: 32920766 BACKGROUND

• Lai YR, Cappellini MD, Aydinok Y, Porter J, Karakas Z, Viprakasit V, Siritanaratkul N, Kattamis A, Liu R, Izquierdo M, Lasher J, Govindaraju S, Taher A. An open-label, multicenter, efficacy, and safety study of deferasirox in iron-overloaded patients with non-transfusion-dependent thalassemia (THETIS): 5-year results. Am J Hematol. 2022 Aug;97(8):E281-E284. doi: 10.1002/ajh.26592. Epub 2022 May 27. No abstract available.

  PMID: 35560253 BACKGROUND

• Klonizakis P, Klaassen R, Sousos N, Liakos A, Tsapas A, Vlachaki E. Evaluation of the Greek TranQol: a novel questionnaire for measuring quality of life in transfusion-dependent thalassemia patients. Ann Hematol. 2017 Nov;96(11):1937-1944. doi: 10.1007/s00277-017-3122-7. Epub 2017 Sep 7.

  PMID: 28884221 BACKGROUND

MeSH Terms

Conditions

Thalassemia; Iron Overload

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Alexandros Ginis, MD

  Elpen Pharmaceutical Co. Inc.

  STUDY DIRECTOR

Central Study Contacts

Alexandros Ginis, MD

CONTACT

+302111865734; a.ginis@elpen.gr

Polyanthi Papanastasiou, BSc, MSc

CONTACT

+302111865777; p.papanastasiou@elpen.gr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 20, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share