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

Cholestasis of Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04281082
• Other study ID #: AlexandraH ICP
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: January 31, 2022

Study information

• Verified date: August 2021
• Source: Alexandra Hospital, Athens, Greece
• Contact: SPYRIDON MICHOPOULOS
• Phone: 00302103381387
• Email: michosp5[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• pregnant women with ICP

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Cholestasis
• Cholestasis of Pregnancy
• Cholestasis, Intrahepatic
• Pregnancy Complications

Intervention

Drug:
• ursofalk
To study the genetic polymorphisms in pregnant women with ICP treated with ursoflak and in their first degree relatives

Locations

Country	Name	City	State
Greece	Alexandra General Hospital	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Alexandra Hospital, Athens, Greece

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	genetic polymorphisms in pregnant women with ICP and in their first degree relatives		01/01/2018-31/01/2021