Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
Study NCT ID:
NCT00700232
Status:
COMPLETED
Last Update Posted:
2010-06-17
First Post:
2008-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ABCB4 Gene Mutations in Intrahepatic Cholestasis of Pregnancy and Controls
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C535932', 'term': 'Intrahepatic Cholestasis of Pregnancy'}, {'id': 'D002779', 'term': 'Cholestasis'}], 'ancestors': [{'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-16', 'studyFirstSubmitDate': '2008-06-13', 'studyFirstSubmitQcDate': '2008-06-17', 'lastUpdatePostDateStruct': {'date': '2010-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['genetics', 'gene expression', 'MDR3', 'estrogens', 'cholestasis', 'pregnancy', 'controls'], 'conditions': ['Intrahepatic Cholestasis of Pregnancy']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'multiparous normal pregnant women (control group)from a single University center', 'healthyVolunteers': True, 'eligibilityCriteria': 'For the control group :\n\nInclusion Criteria:\n\n* pregnant woman (age \\> 18 years) during the third trimester\n* caucasian and born in France\n* multiparous (with at least 2 full term pregnancies)\n* with informed written consent\n\nExclusion Criteria:\n\n* generalized pruritus and/or liver disease during pregnancy\n* liver disease secondary to oral contraception\n* Chronic liver disease\n* disease during current pregnancy'}, 'identificationModule': {'nctId': 'NCT00700232', 'briefTitle': 'ABCB4 Gene Mutations in Intrahepatic Cholestasis of Pregnancy and Controls', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': 'Mutations and Polymorphisms of Gene ABCB4 Among Women Suffering From Intrahepatic Cholestasis of Pregnancy. A Study With a Control Group.', 'orgStudyIdInfo': {'id': 'AOHP06-YB GEN CIG'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Normal multiparous pregnant women without intrahepatic cholestasis of pregnancy (control group)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'Service de Gynécologie Obstétrique CHRU Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'BACQ Yannick, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Service d'hépato-gastro-entérologie CHRU Tours"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'University Hospital, Tours', 'oldOrganization': 'University Hospital, Tours'}}}}