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NCT04917978 Clinical Trial

Association of Hb F Level With Clinical Severity of Beta Thalassemia

Beta Thalassemia Clinical Trial

Official title:
Association of Hb F Level With Clinical Severity of Beta Thalassemia

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04917978
Other study ID # HbF-Beta thalassemia
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2019
Est. completion date December 30, 2025

Study information
Verified date May 2021
Source Nanfang Hospital of Southern Medical University
Contact Xiangmin Xu, Prof. Dr.
Phone 02061648293
Email xixm@smu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The production of Hb F after birth is an important factor in modifying the clinical severity of beta thalassemia because an increased gamma-globin level will bind the additional a-globin and form Hb F. The objective of this project is to evaluate the association of Hb F level with phenotypic diversity of patients with beta thalassemia.

Recruitment information / eligibility
Status Recruiting
Enrollment 1200
Est. completion date December 30, 2025
Est. primary completion date December 30, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Diagnosed with beta-thalassemia Exclusion Criteria: - Iron Deficiency Anemia

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Hematological Phenotype Analysis
Hematological parameters were determined with an automated hematology analyzer (Sysmex, Japan), and hemoglobin analysis was performed with either high-performance liquid chromatography (Bio- Rad, USA) or capillary electrophoresis (Sebia, France and Helena, USA).

Locations
Country Name City State
China Southern Medical University Guangzhou Guangdong

Sponsors (6)
Lead Sponsor Collaborator
Nanfang Hospital of Southern Medical University Jiangmen Maternity and Child Health Care Hospital, Shenzhen Children's Hospital, Shenzhen Second People's Hospital, Yongzhou Maternity and Child Health Hospital, ZhuHai Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hb F level and severity of anemia Observational study that analyzed association of Hb F level and anemia severity in patients 3 years
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