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临床试验/CTRI/2023/12/060743
CTRI/2023/12/060743尚未招募不适用

Phenotype, clinical profile and treatment eligibility of Hepatitis-B infected patients lying in gray zone in a tertiary care center of Eastern India - an observational study.

I.P.G.M.R, Kolkata1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2023年12月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
350
试验地点
1
主要终点
Liver stiffness measure and histopathological changes (Liver Biopsy)

研究概览

简要总结

EASL has described 4 well defined stages of hepatitis B infection pertaining to well characterised immunological states – based on HBV DNA levels and ALT levels as biochemical surrogate for necro-inflammation. There however remain states in between where there is in- congruity between viral dynamics (HBV DNa levels and Hepatitis B  e antigen status) and ALT levels – these are known as grey zones. Individuals in the grey zone can be up to 1/3rd of all treatment naïve new CHB patients These patient populations have not been properly characterised– especially since increasing Volume of literature suggest grey zones of hepatitis B are not benign and not always quiescent – there are ongoing disease activity even progressing to higher levels of Liver fibrosis.

This study aims to characterise these grey zone population – including and up to histopathological evidence of disease activity and liver fibrosis. It aims to explore the hypothesis that significant underlying liver disease activity might be present in clinical grey zones and also describe the distribution of these baseline and further characteristics among grey zone subgroups.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Hepatitis B patients
  • Age > 18 years
  • Fulfilling Gray zone criteria a) Grey zone A (GZ- A): HBeAg positive, normal ALT levels and serum HBV DNA <106 IU/ml; b) Grey zone B (GZ- B): HBeAg positive, elevated ALT levels and serum HBV DNA <2 × 104 IU/ml; c) Grey zone C (GZ- C): HBeAg negative, normal ALT levels and serum HBV DNA <2 × 10 3 IU/ml; d) Grey zone D (GZ- D): HBeAg negative, elevated ALT levels and serum HBV DNA>2 × 10 3 IU/ml.

排除标准

  • subjects unwilling to give consent
  • subjects on treatment or features of Cirrhosis.

结局指标

主要结局

Liver stiffness measure and histopathological changes (Liver Biopsy)

时间窗: At baseline

次要结局

未报告次要终点

研究者

发起方
I.P.G.M.R, Kolkata
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Sk Mahiuddin Ahammed

IPGMEr and SSKM hospital, Kolkata

研究点 (1)

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