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
-
-
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
|
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.
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.