Chronic Hepatitis b Clinical Trial
Official title:
Impact of Hepatitis B Virus Genotype on Treatment Response in Children With Chronic Hepatitis B
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.
| Status | Recruiting |
| Enrollment | 84 |
| Est. completion date | January 1, 2026 |
| Est. primary completion date | January 1, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 2 Years to 16 Years |
| Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Vietnam | Children's Hospital 1 | Ho Chi Minh City | |
| Vietnam | City Children's Hospital | Ho Chi Minh City |
| Lead Sponsor | Collaborator |
|---|---|
| Ly Hoa Anh Minh |
Vietnam,
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. — View Citation
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Biochemical response | Biochemical response is defined as normalisation of ALT levels | 12 months after treatment | |
| Primary | 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. | 12 months after treatment | |
| Secondary | Virological response | Virological response is defined as undetectable HBV DNA by a sensitive PCR assay. | 12 months after treatment |
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