NCT04917978

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

June 11, 2021

Status Verified

May 1, 2021

Enrollment Period

5.1 years

First QC Date

June 3, 2021

Last Update Submit

June 8, 2021

Conditions

Beta Thalassemia

Outcome Measures

Primary Outcomes (1)

  • Hb F level and severity of anemia

    Observational study that analyzed association of Hb F level and anemia severity in patients

    3 years

Study Arms (1)

beta thalassemia patients

Diagnostic Test: Hematological Phenotype Analysis

Interventions

Hematological Phenotype AnalysisDIAGNOSTIC_TEST

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).

beta thalassemia patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

β-thalassemia patients from Southern China

You may qualify if:

  • Diagnosed with beta-thalassemia

You may not qualify if:

  • Iron Deficiency Anemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

beta-Thalassemia

Condition Hierarchy (Ancestors)

ThalassemiaAnemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Xiangmin Xu, Prof. Dr.

CONTACT

02061648293xixm@smu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2021

First Posted

June 8, 2021

Study Start

December 1, 2019

Primary Completion

December 30, 2024

Study Completion

December 30, 2025

Last Updated

June 11, 2021

Record last verified: 2021-05

Locations

CN(1)