Impact of Hepatitis B Virus Genotype on Treatment Response in Children With Chronic Hepatitis B
NCT ID: NCT06289725
Last Updated: 2024-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
84 participants
OBSERVATIONAL
2024-01-01
2026-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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patients with genotype B
antiviral treatment
The patient was treated with antiviral drugs according to the protocol of the Ministry of Health of Vietnam 2019
patients with genotype C
antiviral treatment
The patient was treated with antiviral drugs according to the protocol of the Ministry of Health of Vietnam 2019
Interventions
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antiviral treatment
The patient was treated with antiviral drugs according to the protocol of the Ministry of Health of Vietnam 2019
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Patients have other chronic liver disease (Wilson, autoimmune hepatitis)
* Patients are being treated with immunosuppressive drugs
* Psychomotor retardation, cerebral palsy, brain sequelae
2 Years
16 Years
ALL
No
Sponsors
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Ly Hoa Anh Minh
OTHER
Responsible Party
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Ly Hoa Anh Minh
PhD student
Locations
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Children's Hospital 1
Ho Chi Minh City, , Vietnam
City Children's Hospital
Ho Chi Minh City, , Vietnam
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Kao 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.
Chien 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.
Other Identifiers
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IRB-VN01002-23932
Identifier Type: -
Identifier Source: org_study_id
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