NCT02626689

To Document the Burden of Illness on the Quality of Life and the Impact on Healthcare Utilization in (Beta) β-thalassemia Subjects Who Are Transfusion Dependent (TD) and Non-transfusion Dependent (NTD) Receiving Standard of Care

Burden of Beta-Thalassemia - Quality of Life and Health Care Resource Utilization- A Prospective Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-site, prospective, observational study implemented in β-thalassemia treatment centers from 5 countries (Italy, Turkey, Greece, Lebanon, and Thailand). Approximately one to two study sites will be identified per country and approximately 20 β-thalassemia subjects will be enrolled per country (10 transfusion dependent (TD) and 10 Non-transfusion dependent (NTD) with a total of approximately 100 subjects. This study will not interfere with or influence the routine clinical management of β-thalassemia patients. Outcomes of interest will be collected prospectively for up to 6 months.

Conditions

• Beta-Thalassemia

Interventions

Type	Name	Description
OTHER	Quality of Life (QOL) questionnaires	Monitoring of FACT-AN, SF-36V2, TransQol, and NTD PRO assessments,
OTHER	Healthcare Resource Utilization	Monitoring and reviewing HealthCare Resource Utilization information.

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-01-03
• Completion: 2017-01-03
• First posted: 2015-12-10
• Last updated: 2017-04-07

Locations

5 sites across 5 countries: Greece, Italy, Lebanon, Thailand, Turkey (Türkiye)