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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

NCT02626689 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2017-04-07

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Xiaohan (Henry) HU, MD, MPH, PhD · Celgene

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-01
Primary Completion
2017-01-03
Completion
2017-01-03

Countries

  • Greece
  • Italy
  • Lebanon
  • Thailand
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02626689 on ClinicalTrials.gov