Actively Recruiting

Age: 3Years - 14Years
All Genders
Healthy Volunteers
NCT05991336

Growth and Development-related Outcomes in Children With Transfusion-dependent Beta-thalassemia After Gene Therapy

Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2023-08-14

100

Participants Needed

1

Research Sites

343 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The investigate will conduct a cohort study to compare the growth and development, metabolism, lifestyle behavior, and health-related quality of life among three groups: children with transfusion-dependent β-thalassemia (TDT) who have received gene therapy, TDT children with lifelong supportive therapy and healthy children.

CONDITIONS

Official Title

Growth and Development-related Outcomes in Children With Transfusion-dependent Beta-thalassemia After Gene Therapy

Who Can Participate

Age: 3Years - 14Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female children aged 3 to 14 years
  • Children with transfusion-dependent beta-thalassemia (TDT) who have received gene therapy
  • Children with TDT without history of gene therapy or allogeneic hematopoietic stem cell transplantation, matched by age and gender
  • Healthy children matched by age and gender
  • Subjects willing and able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Diagnosis of compound alpha-thalassemia
  • Uncontrolled systemic fungal, bacterial, or viral infection
  • History of malignant solid tumors, myeloproliferative or immunodeficiency diseases
  • Diagnosed with mental illness
  • Considered ineligible by the investigator for other reasons
  • Subjects unwilling or unable to continue participation
  • Subjects receiving gene therapy or allogeneic hematopoietic stem cell transplantation during the study
  • Subjects seriously non-compliant with study requirements
  • Subjects lost to follow-up

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Regenerative Medicine Center

Tianjin, Tianjin Municipality, China

Actively Recruiting

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Research Team

J

Jun Shi, PhD

CONTACT

J

Jingyu Zhao, MPH

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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