Association of Hb F Level With Clinical Severity of Beta Thalassemia
Sponsor
Nanfang Hospital of Southern Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04917978
Collaborator
ZhuHai Hospital (Other), Shenzhen Children's Hospital (Other), Shenzhen Second People's Hospital (Other), Jiangmen Maternity and Child Health Care Hospital (Other), Yongzhou Maternity and Child Health Hospital (Other)
1,200
1
73
16.4
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
1200 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Association of Hb F Level With Clinical Severity of Beta Thalassemia
Actual Study Start Date
:
Dec 1, 2019
Anticipated Primary Completion Date
:
Dec 30, 2024
Anticipated Study Completion Date
:
Dec 30, 2025
Arms and Interventions
| Arm | 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).
|
Outcome Measures
Primary Outcome Measures
- Hb F level and severity of anemia [3 years]
Observational study that analyzed association of Hb F level and anemia severity in patients
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Diagnosed with beta-thalassemia
Exclusion Criteria:
- Iron Deficiency Anemia
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Southern Medical University | Guangzhou | Guangdong | China | 510515 |
Sponsors and Collaborators
- Nanfang Hospital of Southern Medical University
- ZhuHai Hospital
- Shenzhen Children's Hospital
- Shenzhen Second People's Hospital
- Jiangmen Maternity and Child Health Care Hospital
- Yongzhou Maternity and Child Health Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT04917978
Other Study ID Numbers:
- HbF-Beta thalassemia
First Posted:
Jun 8, 2021
Last Update Posted:
Jun 11, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: