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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with genotype B |
| ||
| patients with genotype C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| antiviral treatment | Drug | The patient was treated with antiviral drugs according to the protocol of the Ministry of Health of Vietnam 2019 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Virological response | Virological response is defined as undetectable HBV DNA by a sensitive PCR assay. | 12 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical response | Biochemical response is defined as normalisation of ALT levels | 12 months after treatment |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Minh Hoa Anh Ly | Contact | (+84) 902352622 | lhaminh.ncs.nhi23@ump.edu.vn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital 1 | Recruiting | Ho Chi Minh City | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29441755 | Background | 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. | |
| 14748059 |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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whole blood
| City Children's Hospital | Recruiting | Ho Chi Minh City | Vietnam |
|
| 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. |
| 14578866 | Result | 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. |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |