Impact of Hepatitis B Virus Genotype on Treatment Response in Children With Chronic Hepatitis B
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Serological response for HBeAg
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
patients with genotype B
干预措施: antiviral treatment (Drug)
patients with genotype C
干预措施: antiviral treatment (Drug)
结局指标
主要结局
Serological response for HBeAg
时间窗: 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.
次要结局
- Virological response(12 months after treatment)
研究者
Ly Hoa Anh Minh
PhD student
University of Medicine and Pharmacy at Ho Chi Minh City