NCT04281082

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 24, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

September 2, 2021

Status Verified

August 1, 2021

Enrollment Period

4.1 years

First QC Date

February 20, 2020

Last Update Submit

August 30, 2021

Conditions

Cholestasis of Pregnancy

Outcome Measures

Primary Outcomes (1)

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

    01/01/2018-31/01/2021

Study Arms (1)

ICP

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

Drug: ursofalk

Interventions

ursofalkDRUG

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

ICP

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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.

You may qualify if:

  • pregnant women with ICP

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandra General Hospital

Athens, 11528, Greece

RECRUITING

MeSH Terms

Conditions

Intrahepatic Cholestasis of Pregnancy

Interventions

Ursodeoxycholic Acid

Intervention Hierarchy (Ancestors)

Deoxycholic AcidCholic AcidsBile Acids and SaltsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholanes

Central Study Contacts

SPYRIDON MICHOPOULOS

CONTACT

00302103381387michosp5@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Of The Gastroenterology Departement

Study Record Dates

First Submitted

February 20, 2020

First Posted

February 24, 2020

Study Start

January 1, 2018

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

September 2, 2021

Record last verified: 2021-08

Locations

GR(1)