Chronic Hepatitis bNCT06289725
Impact of Hepatitis B Virus Genotype on Treatment Response in Children With Chronic Hepatitis B
An observational study of Chronic Hepatitis b, run by Ly Hoa Anh Minh at 2 sites in Vietnam.
Trial summary
The study aimed to evaluate the relationship between hepatitis B virus genotype and treatment response in children with chronic hepatitis B with specific treatment indications. This is a prospective cohort study, with a follow-up period of at least 12 months, conducted at Children's Hospital 1 and City Children's… Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Chronic Hepatitis b
- What is being tested?
- antiviral treatment
- How many people
- 84 participants
- Where
- 2 sitesVietnam
- Study dates
- 1 Jan 2024to 1 Jan 2026
- 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 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients with chronic hepatitis B are indicated for drug treatment antiviral treatment at Children's Hospital 1 and City Children's Hospital, Ho Chi Minh City, Vietnam.
Who may be able to join
- Children from 2 years old to under 16 years old are diagnosed with hepatitis B chronic disease AND
- HBsAg or HBV DNA: positive for at least six months AND
- Liver enzyme ALT: continuously increased by> 70 for male and > 50 for female (> 2 x ULN) AND
- The virus is proliferating: HBV DNA above 20,000 IU/mL (if HBeAg positive) OR HBV DNA above 2,000 IU/mL (if HBeAg negative) AND
- A parent or legal guardian of the pediatric patient obtains consent for them to participate in research.
Who cannot join
- HIV and hepatitis C co-infection
- Patients have other chronic liver disease (Wilson, autoimmune hepatitis)
- Patients are being treated with immunosuppressive drugs
- Psychomotor retardation, cerebral palsy, brain sequelae
Trial locations and contacts
2 sites in 1 country.
Vietnam2 sites, 2 recruiting
- Recruiting
Children's Hospital 1
Ho Chi Minh City
Minh Hoa Anh Ly, 0902352622, lhaminh.ncs.nhi23@ump.edu.vn
- Recruiting
City Children's Hospital
Ho Chi Minh City
Minh Hoa Anh Ly, lhaminh.ncs.nhi23@ump.edu.vn
About this study
The study aimed to evaluate the relationship between hepatitis B virus genotype and treatment response in children with chronic hepatitis B with specific treatment indications. This is a prospective cohort study, with a follow-up period of at least 12 months, conducted at Children's Hospital 1 and City Children's Hospital, Ho Chi Minh City, Vietnam. The patient's blood was taken to be tested for hepatitis B virus genotyping using Sanger sequencing at the Center for Molecular Biomedicine Ho Chi Minh City. The research hypothesis is that genotype is related to treatment response.
- Conditions
- Chronic Hepatitis b
- Being tested
- antiviral treatment
- Keywords
- Hepatitis B, treatment response, genotype, children
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antiviral treatmentDrug
The patient was treated with antiviral drugs according to the protocol of the Ministry of Health of Vietnam 2019
| Study group | Role | What they receive |
|---|---|---|
| patients with genotype B | Not described Receives: Drug: antiviral treatment | |
| patients with genotype C | Not described Receives: Drug: antiviral treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serological response for HBeAg
Serological response for HBeAg applies only to patients with HBeAg-positive Chronic Hepatitis B and is defined as HBeAg loss and seroconversion to anti-HBe.
Measured: 12 months after treatment
Secondary outcomes (1)
Virological response
Virological response is defined as undetectable HBV DNA by a sensitive PCR assay.
Measured: 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start1 Jan 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis bStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ly Hoa Anh Minh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ly Hoa Anh Minh, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289725
- Sponsor's protocol ID
- IRB-VN01002-23932
- Status last verified
- Mar 2024
- First submitted
- 24 Feb 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee KJ, Choe BH, Choe JY, Kim JY, Jeong IS, Kim JW, Yang HR, Chang JY, Kim KM, Moon JS, Ko JS. A Multicenter Study of the Antiviral Efficacy of Entecavir Monotherapy Compared to Lamivudine Monotherapy in Children with Nucleos(t)ide-naive Chronic Hepatitis B. J Korean Med Sci. 2018 Feb 19;33(8):e63. doi: 10.3346/jkms.2018.33.e63.
PubMed 29441755Kao JH, Chen PJ, Lai MY, Chen DS. Hepatitis B virus genotypes and spontaneous hepatitis B e antigen seroconversion in Taiwanese hepatitis B carriers. J Med Virol. 2004 Mar;72(3):363-9. doi: 10.1002/jmv.10534.
PubMed 14748059Chien RN, Yeh CT, Tsai SL, Chu CM, Liaw YF. Determinants for sustained HBeAg response to lamivudine therapy. Hepatology. 2003 Nov;38(5):1267-73. doi: 10.1053/jhep.2003.50458.
PubMed 14578866
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Hepatitis B Virus Genotype on Treatment Response in Children With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT06289725
- Acronym / sponsor ID
- IRB-VN01002-23932
- Conditions
- Chronic Hepatitis b
- Keywords
- Hepatitis B, treatment response, genotype, children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Ly Hoa Anh MinhUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 4 Mar 2024 (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.
The study aimed to evaluate the relationship between hepatitis B virus genotype and treatment response in children with chronic hepatitis B with specific treatment indications. This is a prospective cohort study, with a follow-up period of at least 12 months, conducted at Children's Hospital 1 and City Children's Hospital, Ho Chi Minh City, Vietnam. The patient's blood was taken to be tested for hepatitis B virus genotyping using Sanger sequencing at the Center for Molecular Biomedicine Ho Chi Minh City. The research hypothesis is that genotype is related to treatment response.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with genotype B | – | Drug: antiviral treatment |
| patients with genotype C | – | Drug: antiviral treatment |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients with chronic hepatitis B are indicated for drug treatment antiviral treatment at Children's Hospital 1 and City Children's Hospital, Ho Chi Minh City, Vietnam.
Key inclusion criteria (5 listed)
- Children from 2 years old to under 16 years old are diagnosed with hepatitis B chronic disease AND
- HBsAg or HBV DNA: positive for at least six months AND
- Liver enzyme ALT: continuously increased by> 70 for male and > 50 for female (> 2 x ULN) AND
- The virus is proliferating: HBV DNA above 20,000 IU/mL (if HBeAg positive) OR HBV DNA above 2,000 IU/mL (if HBeAg negative) AND
- A parent or legal guardian of the pediatric patient obtains consent for them to participate in research.
Key exclusion criteria (4 listed)
- HIV and hepatitis C co-infection
- Patients have other chronic liver disease (Wilson, autoimmune hepatitis)
- Patients are being treated with immunosuppressive drugs
- Psychomotor retardation, cerebral palsy, brain sequelae
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antiviral treatmentThe patient was treated with antiviral drugs according to the protocol of the Ministry of Health of Vietnam 2019 | Drug | patients with genotype B, patients with genotype C |
Primary outcome
Serological response for HBeAg
Time frame: 12 months after treatment
Serological response for HBeAg applies only to patients with HBeAg-positive Chronic Hepatitis B and is defined as HBeAg loss and seroconversion to anti-HBe.
1 secondary outcome
Virological response
Time frame: 12 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Background: PubMed 29441755Lee KJ, Choe BH, Choe JY, Kim JY, Jeong IS, Kim JW, Yang HR, Chang JY, Kim KM, Moon JS, Ko JS. A Multicenter Study of the Antiviral Efficacy of Entecavir Monotherapy Compared to Lamivudine Monotherapy in Children with Nucleos(t)ide-naive Chronic Hepatitis B. J Korean Med Sci. 2018 Feb 19;33(8):e63. doi: 10.3346/jkms.2018.33.e63.
- Results publication: PubMed 14748059Kao JH, Chen PJ, Lai MY, Chen DS. Hepatitis B virus genotypes and spontaneous hepatitis B e antigen seroconversion in Taiwanese hepatitis B carriers. J Med Virol. 2004 Mar;72(3):363-9. doi: 10.1002/jmv.10534.
- Results publication: PubMed 14578866Chien RN, Yeh CT, Tsai SL, Chu CM, Liaw YF. Determinants for sustained HBeAg response to lamivudine therapy. Hepatology. 2003 Nov;38(5):1267-73. doi: 10.1053/jhep.2003.50458.
- Individual participant dataSharing planned: No
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Chronic Hepatitis B
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis b, run by Ly Hoa Anh Minh at 2 sites in Vietnam.
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 5 inclusion and 4 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 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. 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 Minh Hoa Anh Ly ((+84) 902352622, lhaminh.ncs.nhi23@ump.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serological response for HBeAg (time frame: 12 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06289725, which also lists 3 linked publications.
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 18 Mar 2024.