Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-02-21 @ 11:35 PM
Study NCT ID:
NCT02701166
Status:
UNKNOWN
Last Update Posted:
2016-03-08
First Post:
2016-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Bezafibrate on Cholestatic Itch
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008105', 'term': 'Liver Cirrhosis, Biliary'}, {'id': 'D015209', 'term': 'Cholangitis, Sclerosing'}, {'id': 'D011537', 'term': 'Pruritus'}, {'id': 'D002779', 'term': 'Cholestasis'}], 'ancestors': [{'id': 'D002780', 'term': 'Cholestasis, Intrahepatic'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002761', 'term': 'Cholangitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001629', 'term': 'Bezafibrate'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D058607', 'term': 'Fibric Acids'}, {'id': 'D058610', 'term': 'Isobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002723', 'term': 'Chlorobenzoates'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-04', 'studyFirstSubmitDate': '2016-03-02', 'studyFirstSubmitQcDate': '2016-03-04', 'lastUpdatePostDateStruct': {'date': '2016-03-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with a reduction in itch intensity of 50% or more', 'timeFrame': '3 weeks'}], 'secondaryOutcomes': [{'measure': 'Serum liver tests', 'timeFrame': '3 weeks'}, {'measure': 'Serum creatinine', 'timeFrame': '3 weeks'}, {'measure': 'Serum cholesterol', 'timeFrame': '3 weeks'}, {'measure': 'Serum autotaxin activity', 'timeFrame': '3 weeks'}, {'measure': 'Serum creatinin kinase', 'timeFrame': '3 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pruritus', 'itch', 'cholestasis'], 'conditions': ['Primary Biliary Cholangitis', 'Primary Sclerosing Cholangitis', 'Secondary Sclerosing Cholangitis']}, 'referencesModule': {'references': [{'pmid': '33031833', 'type': 'DERIVED', 'citation': 'de Vries E, Bolier R, Goet J, Pares A, Verbeek J, de Vree M, Drenth J, van Erpecum K, van Nieuwkerk K, van der Heide F, Mostafavi N, Helder J, Ponsioen C, Oude Elferink R, van Buuren H, Beuers U; Netherlands Association for the Study of the Liver-Cholestasis Working Group. Fibrates for Itch (FITCH) in Fibrosing Cholangiopathies: A Double-Blind, Randomized, Placebo-Controlled Trial. Gastroenterology. 2021 Feb;160(3):734-743.e6. doi: 10.1053/j.gastro.2020.10.001. Epub 2020 Oct 5.'}, {'pmid': '28535810', 'type': 'DERIVED', 'citation': 'Bolier R, de Vries ES, Pares A, Helder J, Kemper EM, Zwinderman K, Elferink RPO, Beuers U; Netherlands Association for the Study of the Liver (NASL) Cholestatic Liver Diseases Study Group. Fibrates for the treatment of cholestatic itch (FITCH): study protocol for a randomized controlled trial. Trials. 2017 May 23;18(1):230. doi: 10.1186/s13063-017-1966-8.'}]}, 'descriptionModule': {'briefSummary': 'Randomized double blind placebo controlled trial to evaluate the antipruritic effect of bezafibrate in patients with moderate to severe cholestatic itch.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of primary biliary cholangitis or primary/secondary sclerosing cholangitis as defined by EASL clinical practice guidelines of cholestasis 2009;\n* itch without primary dermatologic abnormalities and with an intensity score of ≥ 5.0 cm on a scale from 0.0 cm (no itch) to 10.0 cm (worst itch possible), scored twice in the week before inclusion.\n\nExclusion Criteria:\n\n* Concomitant guideline-recommended as well as experimental antipruritic therapy, e.g.\n\nrifampicin, opioid-receptor antagonists (naltrexon, naloxone), serotonin-reuptake inhibitors (sertraline), ondansetron, phenobarbital, propofol, lidocaine, dronabinol, butorphanol, internal or external biliary drainage, extracorporeal albumin dialysis, ultraviolet-B phototherapy; NB. Topical menthol containing agents are allowed, as well as bile salt sequestrants (colesevelam, cholestyramin) as long as taken at least 4 hours before or after intake of the study medication. Incidental use of these agents should be noted by patients in the diary, structural use should be noted on the CRF (section co-medication);\n\n* Pregnancy, women of childbearing potential not using contraception, breast feeding;\n* Cholestasis due to obstruction that requires invasive desobstructive treatment within the time scope of the study (5 weeks), such as endoscopic retrograde cholangiopancreaticography (ERCP) or surgical removal of a tumor compressing the bile duct;\n* Use of opiates;\n* Renal insufficiency (creatinine clearance \\<60mL/min).'}, 'identificationModule': {'nctId': 'NCT02701166', 'acronym': 'FITCH', 'briefTitle': 'The Effect of Bezafibrate on Cholestatic Itch', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'The Effect of Bezafibrate on Cholestatic Itch', 'orgStudyIdInfo': {'id': 'NL48885.018.15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bezafibrate', 'description': 'Bezalip retard 400mg tablet', 'interventionNames': ['Drug: Bezafibrate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo 400mg tablet', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Bezafibrate', 'type': 'DRUG', 'otherNames': ['bezalip'], 'description': 'bezafibrate 400mg per day', 'armGroupLabels': ['Bezafibrate']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo 400mg per day', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amsterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Ulrich Beuers, prof. dr.', 'role': 'CONTACT', 'email': 'u.h.beuers@amc.uva.nl', 'phone': '+31205662422'}, {'name': 'Ruth Bolier', 'role': 'CONTACT', 'email': 'a.r.bolier@amc.uva.nl', 'phone': '+31205668701'}, {'name': 'Ulrich Beuers, prof. dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Elsemieke de Vries', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Academic Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Amsterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Karin van Nieuwkerk, dr.', 'role': 'CONTACT', 'email': 'cmj.vannieuwkerk@vumc.nl', 'phone': '+31-20-4440613'}, {'name': 'Ineke Jansen', 'role': 'CONTACT', 'email': 'a.jansen1@vumc.nl', 'phone': '+31-20-4449455'}], 'facility': 'Vrije Universiteit Medisch Centrum', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Groningen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Marleen de Vree, dr.', 'role': 'CONTACT', 'email': 'j.m.l.de.vree@umcg.nl', 'phone': '+31-6-55256255'}, {'name': 'Lyda Engelsman', 'role': 'CONTACT', 'email': 'a.f.engelsman@umcg.nl', 'phone': '+31-50-3614996'}], 'facility': 'Universitair Medisch Centrum Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Leiden', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Bart van Hoek, prof. dr.', 'role': 'CONTACT', 'email': 'b.van_hoek@lumc.nl', 'phone': '+31-71-5263507'}, {'name': 'Lida Beneken Kolmer', 'role': 'CONTACT', 'email': 'a.beneken_kolmer@lumc.nl', 'phone': '+31-71-5261188'}], 'facility': 'Leids Universitair Medisch Centrum', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'city': 'Maastricht', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Peter Jansen, prof. dr.', 'role': 'CONTACT', 'email': 'plm.jansen@maastrichtuniversity.nl', 'phone': '+31-43-3876543'}, {'name': 'Tine Horsten', 'role': 'CONTACT', 'email': 't.horsten@mumc.nl', 'phone': '+31-43-3874436'}], 'facility': 'Maastricht Universitair Medisch Centrum', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'city': 'Nijmegen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Joost Drenth, prof. dr.', 'role': 'CONTACT', 'email': 'joostphdrenth@cs.com', 'phone': '+31-24-3613999'}, {'name': 'Sonja Cuppen', 'role': 'CONTACT', 'email': 'researchunit.mdl@radboudumc.nl', 'phone': '+31-24-3619190'}], 'facility': 'Radboud Universitair Medisch Centrum', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Rotterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Henk van Buuren, dr.', 'role': 'CONTACT', 'email': 'h.vanbuuren@erasmusmc.nl', 'phone': '+31-10-7035942'}, {'name': 'Maren Harms', 'role': 'CONTACT', 'email': 'm.h.harms@erasmusmc.nl', 'phone': '+31-10-7038922'}], 'facility': 'Erasmus Medisch Centrum', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Utrecht', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Karel van Erpecum, dr.', 'role': 'CONTACT', 'email': 'k.j.vanerpecum@umcutrecht.nl', 'phone': '+31-88-7555555'}, {'name': 'Janneke van den Brink', 'role': 'CONTACT', 'email': 'j.vandenbrink@umcutrecht.nl', 'phone': '+31-88-7557973'}], 'facility': 'Universitair Medisch Centrum Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'city': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Albert Parés, dr.', 'role': 'CONTACT', 'email': 'pares@ub.edu', 'phone': '+34-93-2275753'}], 'facility': 'University of Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'collaborators': [{'name': 'Erasmus Medical Center', 'class': 'OTHER'}, {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, {'name': 'Leiden University Medical Center', 'class': 'OTHER'}, {'name': 'UMC Utrecht', 'class': 'OTHER'}, {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, {'name': 'Free University Medical Center', 'class': 'OTHER'}, {'name': 'University of Barcelona', 'class': 'OTHER'}, {'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}, {'name': 'Friedrich-Alexander-Universität Erlangen-Nürnberg', 'class': 'OTHER'}, {'name': 'Istituto Clinico Humanitas', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'prof. dr. Ulrich Beuers', 'investigatorFullName': 'Ruth Bolier', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}