Reactivation of Hepatitis B VirusNCT03529760
Chemotherapy Efficacy and Follow-up Study of Hepatitis B Virus Infection and Reactivation in Children With Leukemia
An observational study of Reactivation of Hepatitis B Virus, run by Children's Hospital of Chongqing Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 1 year to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Reactivation of Hepatitis B Virus
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2018to 30 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 1-16-year-old leukemia hospitalized chemotherapy children
Who may be able to join
- The clinical diagnosis of children with leukemia received systemic chemotherapy.
Who cannot join
- Children with non-leukemia and children without appropriate treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chongqing Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400014
Yao Zhao
About this study
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.
Read the detailed 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.
- Conditions
- Reactivation of Hepatitis B Virus
- Keywords
- Leukemia, occult hepatitis B virus infection
- Medical subject headings
- Leukemia
What is being measured
The primary outcome is the main question the study is designed to answer.
HBV-DNA positive
Positive HBV nucleic acid test
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start8 May 2018
- Primary completion15 Jul 2019 (estimated)
- Study completion30 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reactivation of Hepatitis B VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiu Li, Children's Hospital of Chongqing Medical University
- Investigators
- Yao Zhao, Study director, Chongqing Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529760
- Sponsor's protocol ID
- 2018-27
- Status last verified
- Jul 2019
- First submitted
- 8 May 2018
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy Efficacy and Follow-up Study of Hepatitis B Virus Infection and Reactivation in Children With Leukemia
- ClinicalTrials.gov ID
- NCT03529760
- Acronym / sponsor ID
- 2018-27
- Conditions
- Reactivation of Hepatitis B Virus
- Keywords
- Leukemia, occult hepatitis B virus infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Children's Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 8 May 2018 (actual)
- Primary completion
- 15 Jul 2019 (estimated)
- Study completion
- 30 May 2020 (estimated)
- First posted
- 18 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 1-16-year-old leukemia hospitalized chemotherapy children
Key inclusion criteria (1 listed)
- The clinical diagnosis of children with leukemia received systemic chemotherapy.
Key exclusion criteria (1 listed)
- Children with non-leukemia and children without appropriate treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HBV-DNA positive
Time frame: 1-year
Positive HBV nucleic acid test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yao Zhao study director
Chongqing Children's Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reactivation of Hepatitis B Virus, run by Children's Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yao Zhao (86-23-6360-3083, Zhaoy@cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBV-DNA positive (time frame: 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019.