Impact of Hepatitis B Virus Genotype on Treatment Response in Children With Chronic Hepatitis B

Chronic Hepatitis b Clinical Trial

Official title:

Impact of Hepatitis B Virus Genotype on Treatment Response in Children With Chronic Hepatitis B

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06289725
• Other study ID #: IRB-VN01002-23932
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: March 2024
• Source: University of Medicine and Pharmacy at Ho Chi Minh City
• Contact: Minh Hoa Anh Ly
• Phone: (+84) 902352622
• Email: lhaminh.ncs.nhi23[@]ump.edu.vn
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Chronic Hepatitis b
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• antiviral treatment
The patient was treated with antiviral drugs according to the protocol of the Ministry of Health of Vietnam 2019

Locations

Country	Name	City	State
Vietnam	Children's Hospital 1	Ho Chi Minh City
Vietnam	City Children's Hospital	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
Ly Hoa Anh Minh

Country where clinical trial is conducted

Vietnam, 

References & Publications (3)

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

Outcome

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