Association of Hb F Level With Clinical Severity of Beta Thalassemia

June 8, 2021 updated by: Nanfang Hospital of Southern Medical University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xiangmin Xu, Prof. Dr.
  • Phone Number: 86 02061648293
  • Email: xixm@smu.edu.cn

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Southern Medical University
        • Contact:
          • Xiangmin Xu, Prof. Dr.
          • Phone Number: 86 02061648293
          • Email: xixm@smu.edu.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

β-thalassemia patients from Southern China

Description

Inclusion Criteria:

  • Diagnosed with beta-thalassemia

Exclusion Criteria:

  • Iron Deficiency Anemia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
beta thalassemia patients
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hb F level and severity of anemia
Time Frame: 3 years
Observational study that analyzed association of Hb F level and anemia severity in patients
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Collaborators

Shenzhen Second People's Hospital
Shenzhen Children's Hospital
ZhuHai Hospital
Jiangmen Maternity and Child Health Care Hospital
Yongzhou Maternity and Child Health Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Anticipated)

December 30, 2024

Study Completion (Anticipated)

December 30, 2025

Study Registration Dates

First Submitted

June 3, 2021

First Submitted That Met QC Criteria

June 7, 2021

First Posted (Actual)

June 8, 2021

Study Record Updates

Last Update Posted (Actual)

June 11, 2021

Last Update Submitted That Met QC Criteria

June 8, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HbF-Beta thalassemia

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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