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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03529760
Other study ID # 2018-27
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 8, 2018
Est. completion date May 30, 2020

Study information

Verified date July 2019
Source Children's Hospital of Chongqing Medical University
Contact Yao Zhao
Phone 86-23-6360-3083
Email Zhaoy@cqmu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Children with clinically diagnosed leukemia may experience occult HBV infection after chemotherapy immunosuppressive therapy, which may affect the normal course of leukemia treatment. However, this is not caused by clinically relevant diagnosis and treatment measures but exists in vivo.


Description:

The clinical diagnosis of children with leukemia may be due to the influence of leukemia disease on the immune cells of the children and the damage to the immune system due to immunosuppressive therapy in children. Therefore, the risk of contracting hepatitis B virus is relatively high, and some children are In the treatment of immunosuppressive chemotherapy (later), the reactivation of occult HBV infection has an impact on the normal course of leukemia treatment. However, this is not a clinically relevant diagnosis and treatment measure. It is necessary to avoid unnecessary conflicts between clinical doctors and patients as much as possible.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date May 30, 2020
Est. primary completion date July 15, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year to 16 Years
Eligibility Inclusion Criteria:

The clinical diagnosis of children with leukemia received systemic chemotherapy.

Exclusion Criteria:

Children with non-leukemia and children without appropriate treatment.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Chongqing Children's Hospital of Chongqing Medical University Chongqing Chongqing

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary HBV-DNA positive Positive HBV nucleic acid test 1-year