Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT01576458
Status:
COMPLETED
Last Update Posted:
2012-04-12
First Post:
2012-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002780', 'term': 'Cholestasis, Intrahepatic'}], 'ancestors': [{'id': 'D002779', 'term': 'Cholestasis'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014580', 'term': 'Ursodeoxycholic Acid'}], 'ancestors': [{'id': 'D003840', 'term': 'Deoxycholic Acid'}, {'id': 'D002793', 'term': 'Cholic Acids'}, {'id': 'D001647', 'term': 'Bile Acids and Salts'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002757', 'term': 'Cholanes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '1998-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-11', 'studyFirstSubmitDate': '2012-02-18', 'studyFirstSubmitQcDate': '2012-04-11', 'lastUpdatePostDateStruct': {'date': '2012-04-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1998-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pruritus', 'timeFrame': 'an average of 5 weeks', 'description': 'visual analogy scale (VAS): 0-10'}, {'measure': 'laboratory values', 'timeFrame': 'an average 5 weeks', 'description': 'Serum levels of alanine aminotransferases and total bile acids were assessed before the treatment and once a week thereafter at least three times or until delivery. Simultaneously serum levels of estradiol, progesterone, prolactin, cholesterol, HDL-cholesterol and triglyserides were assessed. Platelet count activated partial thromboplastin time and fibrinogen D-dimers were measured as well.'}], 'secondaryOutcomes': [{'measure': 'Obstetrical surveillance', 'timeFrame': '2-12 weeks', 'description': 'Data on pregnancy and delivery outcome was recorded and analysed.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ursodeoxycholic acid', 'intrahepatic cholestasis', 'pregnancy'], 'conditions': ['Intrahepatic Cholestasis', 'Pregnancy']}, 'referencesModule': {'references': [{'pmid': '23978872', 'type': 'DERIVED', 'citation': 'Joutsiniemi T, Timonen S, Leino R, Palo P, Ekblad U. Ursodeoxycholic acid in the treatment of intrahepatic cholestasis of pregnancy: a randomized controlled trial. Arch Gynecol Obstet. 2014 Mar;289(3):541-7. doi: 10.1007/s00404-013-2995-5. Epub 2013 Aug 27.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the efficacy and safety of ursodeoxycholic acid (UDCA) in the treatment of patients with intrahepatic cholestasis of pregnancy (ICP).\n\nIn the randomised (double-blind, placebo-controlled) study 20 pregnant women with ICP received (random allocation of) either 450 mg/day UDCA or placebo for 14 days during the third trimester of pregnancy. The severity of pruritus was registered. Itching scores and serum levels of alanine aminotransferase, total bile acids, estradiol, progesterone, prolactin, cholesterol, HDL-cholesterol, triglycerides, activated partial thromboplastin time (APTT), fibrinogen D-dimers (FIDD) and platelet count were assessed before the treatment and weekly thereafter. Data on pregnancy and delivery outcome was recorded and analysed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women with intrahepatic cholestasis of pregnancy'}, 'identificationModule': {'nctId': 'NCT01576458', 'briefTitle': 'Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turku University Hospital'}, 'officialTitle': 'Randomised Placebo-controlled Study of Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy', 'orgStudyIdInfo': {'id': '73/180/2011'}, 'secondaryIdInfos': [{'id': '73/180/2011', 'type': 'REGISTRY', 'domain': 'URSODEOXYCHOLIC ACID AND INTRAHEPATIC CHOLESTASIS OF PREGNANCY'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ursodeoxycholic acid', 'description': '10 pregant women with intrahepatic cholestasis of pregnancy', 'interventionNames': ['Drug: ursodeoxycholic acid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'placebo', 'description': '10 pregnant women with intrahepatic cholestasis of pregnancy', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ursodeoxycholic acid', 'type': 'DRUG', 'description': '450 mg/day for 14 days', 'armGroupLabels': ['ursodeoxycholic acid']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20520', 'city': 'Turku', 'country': 'Finland', 'facility': 'Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'overallOfficials': [{'name': 'Susanna Timonen, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Turku University Hospital'}, {'name': 'Ulla Ekblad, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Turku University Hospital'}, {'name': 'Riitta Leino, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Turku University Hospital'}, {'name': 'Pertti Palo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Turku University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Titta Joutsiniemi', 'investigatorAffiliation': 'Turku University Hospital'}}}}