Growth and Development, Health-related Quality of Life of Children With Transfusion-dependent Beta-thalassemia After Gene Therapy

Status: Recruiting
Location: See location...
Intervention Type: Genetic
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 14
Healthy Volunteers: t
View:

⁃ Gene therapy group-inclusion

• Male or female age of 3-14 years

• TDT Children who have received gene therapy.

• Subjects who are willing and able to provide written informed consent.

⁃ Supportive therapy group-inclusion

• Gender same as the matched case

• Age similar to the matched case

• Children with β-TDT

• No history of gene therapy or allogeneic hematopoietic stem cell transplantation

• Subjects who are willing and able to provide written informed consent.

⁃ Healthy children group-inclusion

• Gender same as the matched case

• Age similar to the matched case

• Subjects who are willing and able to provide written informed consent.

Locations
Other Locations
China
Regenerative Medicine Center
RECRUITING
Tianjin
Contact Information
Primary
Jun Shi, PhD
shijun@ihcams.ac.cn
2223900913
Backup
Jingyu Zhao, MPH
zhaojingyu@ihcams.ac.cn
13752253515
Time Frame
Start Date: 2023-06-05
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 100
Treatments
Gene therapy group
TDT Children who have received gene therapy between 3\~14 years old.
Supportive therapy group
TDT Children who received lifelong treatment with blood transfusions and iron chelation. They were selected based on the age and sex of the gene therapy group.
Healthy children group
Healthy children were selected based on the age and sex of the gene therapy group.
Sponsors
Leads: Institute of Hematology & Blood Diseases Hospital, China

This content was sourced from clinicaltrials.gov