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ABCB4 Gene Mutations in Intrahepatic Cholestasis of Pregnancy and Controls

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00700232
Recruitment Status : Completed
First Posted : June 18, 2008
Last Update Posted : June 17, 2010
Sponsor:
Information provided by:
University Hospital, Tours

Tracking Information
First Submitted Date June 13, 2008
First Posted Date June 18, 2008
Last Update Posted Date June 17, 2010
Study Start Date July 2006
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title ABCB4 Gene Mutations in Intrahepatic Cholestasis of Pregnancy and Controls
Official Title Mutations and Polymorphisms of Gene ABCB4 Among Women Suffering From Intrahepatic Cholestasis of Pregnancy. A Study With a Control Group.
Brief Summary

Mutations of the ATP binding cassette subfamily B member 4 (ABCB4) gene, a gene involved in a subtype of progressive familial intrahepatic cholestasis, have been reported in women suffering from intrahepatic cholestasis of pregnancy. The true incidence and the role of these ABCB4 gene mutations in patients suffering from intrahepatic cholestasis of pregnancy have not been clearly established.

The aim of the present study is to describe the nature and frequency of these mutations in a series of patients with intrahepatic cholestasis of pregnancy and to compare with a control group of pregnant women without intrahepatic cholestasis of pregnancy.

Detailed Description

Intrahepatic cholestasis of pregnancy was defined by pruritus and elevated serum alanine aminotransferase activity or bile acid concentration, with recovery after delivery. Patients with intercurrent liver disease were excluded.

The entire ABCB4 gene coding sequence and the promoter region were analyzed, during the routine medical management, by single strand conformation polymorphism and/or sequencing in 50 unrelated Caucasian patients with intrahepatic cholestasis of pregnancy.

The genomic variants detected in these patients with intrahepatic cholestasis of pregnancy will be sought in 100 control women from Caucasian origin recruited in the same hospital.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
blood samples
Sampling Method Non-Probability Sample
Study Population multiparous normal pregnant women (control group)from a single University center
Condition Intrahepatic Cholestasis of Pregnancy
Intervention Not Provided
Study Groups/Cohorts 1
Normal multiparous pregnant women without intrahepatic cholestasis of pregnancy (control group)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June¬†17,¬†2008)
120
Original Estimated Enrollment Same as current
Actual Study Completion Date July 2009
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

For the control group :

Inclusion Criteria:

  • pregnant woman (age > 18 years) during the third trimester
  • caucasian and born in France
  • multiparous (with at least 2 full term pregnancies)
  • with informed written consent

Exclusion Criteria:

  • generalized pruritus and/or liver disease during pregnancy
  • liver disease secondary to oral contraception
  • Chronic liver disease
  • disease during current pregnancy
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT00700232
Other Study ID Numbers AOHP06-YB GEN CIG
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Tours
Study Sponsor University Hospital, Tours
Collaborators Not Provided
Investigators
Study Director: BACQ Yannick, MD Service d'hépato-gastro-entérologie CHRU Tours
PRS Account University Hospital, Tours
Verification Date June 2010