Cohort Hepatitis B Virus (HBV) Pediatric Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 462
- 试验地点
- 7
- 主要终点
- Antigen loss: e and s
研究概览
简要总结
The purpose of this study is to describe participants 6 months to <18 years of age with hepatitis B virus (HBV) infection in a prospective cohort in the United States (US) and Canada and identify predictors of disease activation and progression.
详细描述
•Primary Aim:
o To describe participants 6 months to <18 years of age with hepatitis B virus (HBV) infection in a prospective cohort in the United States (US) and Canada and identify predictors of disease activation and progression
Secondary Aims:
- To describe clinical, virological, and immunological characteristics of participants with HBV in the US and Canada.
- To evaluate changes in HBV infection status and hepatitis B surface antigen (HBsAg) levels and factors associated with those changes.
- To verify whether a baseline HBsAg below 1,000 IU/mL and HBV DNA below 1,000 IU/mL is an accurate predictor of people who are, or who will become, inactive carriers, defined as people who are HBsAg positive, hepatitis B "e" antigen (HBeAg) negative, have normal alanine aminotransferase (ALT) and HBV DNA under 1,000 IU/mL on at least two occasions over a period of at least 6 months with HBV DNA under 1,000 IU/mL.
- To assess the health related quality of life (HRQOL) of treatment naïve hepatitis B surface antigen (HBsAg) positive children and adolescents
- To develop a bank of biospecimens (e.g., serum, plasma, DNA, liver tissue) obtained from participants with HBV infection.
- To identify pediatric participants from 2 years to <18 years of age with chronic HBV infection for potential participation in treatment study to be conducted by the Hepatitis B Research Network (HBRN).
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
- 6 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent/assent as appropriate
- •At least 6 months to <18 years of age
- •Hepatitis B surface antigen (HBsAg) positive
排除标准
- •Hepatic decompensation
- •Hepatocellular carcinoma (HCC)
- •Liver transplantation
- •Current Hepatitis B antiviral treatment (except pregnant females)
- •Known coinfection with HIV (patients with hepatitis D or hepatitis C coinfection are not excluded)
- •Medical or social condition which in the opinion of the principal investigator would interfere with or prevent regular follow up.
- •Unable or unwilling to return for regular follow-up
结局指标
主要结局
Antigen loss: e and s
时间窗: up to 288 weeks
Loss of these viral markers may be associated with appearance of corresponding antibodies in serum (anti-HBe or anti-HBs). HBsAg loss appears to represent a "cure" of HBV infection and is associated with reduction, but not necessarily elimination, of the risk of future complications, such as Hepatocellular carcinoma (HCC) which may occur, particularly in those who lose HBsAg at an older age (after 50 years) or after the development of cirrhosis. When HBeAg or HBsAg loss occurs, participants will be followed more closely initially and then return to the regular follow-up schedule.
次要结局
- Cirrhosis(up to 288 weeks)
- Reaching 18 years of Age(up to 288 weeks)
- Hepatitis exacerbation marked by alanine aminotransferase (ALT) Flare(up to 288 weeks)
- Hepatocellular carcinoma (HCC)(up to 288 weeks)
- Liver transplantation(up to 288 weeks)
- Hepatic Decompensation(up to 288 weeks)
- Death(up to 288 weeks)
研究者
Anna Lok
Study Chair
University of Michigan