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临床试验/NCT04281082
NCT04281082Unknown不适用

Genetic Polymorphisms of ABCB11 and ABCB4 in Women With Intrahepatic Cholestasis of Pregnancy (ICP) and in Their First Degree Relatives

Alexandra Hospital, Athens, Greece1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
genetic polymorphisms in pregnant women with ICP and in their first degree relatives

研究概览

简要总结

To assess the occurrence of 11 SNP's in ABCB11 and ABCB4 genes in Greek women with ICP compared with healthy pregnant women. Moreover, these genetic polymorphisms will be examined in their first-degree relatives.

详细描述

Introduction

ICP is commolnly manifested in the 2nd and especially in the 3rd trimester of pregnancy. Pathogenesis of ICP is multifactorial implicating genetic, environmental and hormonologic factors. Prevalence of ICP varies. In certain populations in latin America occurrence of ICP is up to 15% of pregnancies. In Caucasian populations incidence of ICP is approximately 1% of pregnancies. Data for the Greek population are scarce. Genes ABCB4 and ABCB11 that are encoding transport proteins in the hepatocyte are implicated in the pathogenesis of ICP.

Aim of the Study: To study the genetic polymorphisms in pregnant women with ICP and in their first degree relatives Patients and Methods: To recruit 100 women with ICP. Analyze the occurrence of 11 SNP's in ABCB11 and ABCB4 genes in women with ICP. As control group will be used pregnant women without ICP or known hepatic disease. In these women the same analysis for SNP's as in women with ICP will be performed. Exclusion criteria: women with known hepatic disease ( HBV, HCV, HIV, HEV, Autoimmune Hepatitis, Drug induced liver injury, cirrhosis) and women with pregnancy related liver disease (pre-eclampsia, acute fatty liver of pregnancy or HELLP syndrome) Inclusion criteria: pregnant women with ICP. Detailed report of medical history, laboratory and clinical data regarding women and the pregnancy. Follow up of laboratory values before and after the begging of treatment with UDCA.

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
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnant women with ICP

排除标准

  • women with known hepatic disease ( HBV, HCV, HIV, HEV, Autoimmune Hepatitis, Drug induced liver injury, cirrhosis)
  • women with pregnancy related liver disease (pre-eclampsia, acute fatty liver of pregnancy or HELLP syndrome)

研究组 & 干预措施

ICP

To study the genetic polymorphisms in pregnant women with ICP and in their first degree relatives

干预措施: ursofalk (Drug)

结局指标

主要结局

genetic polymorphisms in pregnant women with ICP and in their first degree relatives

时间窗: 01/01/2018-31/01/2021

次要结局

未报告次要终点

研究者

发起方
Alexandra Hospital, Athens, Greece
申办方类型
Other
责任方
Principal Investigator
主要研究者

SPYRIDON MICHOPOULOS

Head Of The Gastroenterology Departement

Alexandra Hospital, Athens, Greece

研究点 (1)

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