Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 11:38 PM
Study NCT ID:
NCT06886360
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-20
First Post:
2025-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study with Norucholic Acid Tablets in Patients with Primary Sclerosing Cholangitis (PSC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015209', 'term': 'Cholangitis, Sclerosing'}], 'ancestors': [{'id': 'D002761', 'term': 'Cholangitis'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-19', 'studyFirstSubmitDate': '2025-03-14', 'studyFirstSubmitQcDate': '2025-03-19', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of treatment emergent adverse events', 'timeFrame': '72 weeks from enrollment to end of treatment'}, {'measure': 'Occurrence of serious treatment emergent adverse events', 'timeFrame': '72 weeks from enrollment to end of treatment'}, {'measure': 'Occurrence of severe treatment emergent adverse events', 'timeFrame': '72 weeks from enrollment to end of treatment'}, {'measure': 'Occurrence of adverse drug reactions', 'timeFrame': '72 weeks from enrollment to end of treatment'}, {'measure': 'Occurrence of unexpected treatment emergent adverse events', 'timeFrame': '72 weeks from enrollment to end of treatment'}, {'measure': 'Occurrence of treatment emergent adverse events leading to study withdrawal', 'timeFrame': '72 weeks from enrollment to end of treatment'}, {'measure': 'Occurrence of adverse events leading to death', 'timeFrame': '72 weeks from enrollment to end of treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Sclerosing Cholangitis']}, 'descriptionModule': {'briefSummary': 'Open-label, multi-center, phase III trial. Oral treatment with 1500 mg norucholic acid in Primary Sclerosing cholangitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n1. Signed informed consent.\n2. Males or females ≥ 18 years.\n3. Patient has previously been diagnosed with PSC, has participated in the previous NUC 5/PSC trial and has completed the DBE phase with Visit 22, or has prematurely terminated the DBE phase before this trial has been started, or has prematurely terminated the DBE phase after this trial has been started, under the condition that the premature termination was due to lack of efficacy\\*. (\\*Lack of efficacy as defined in the NUC-5/PSC trial.)\n\nExclusion Criteria:\n\n1. History or presence of chronic alcoholic consumption (daily consumption \\> 30 g in men, \\> 20 g in women).\n2. Patients who discontinued study participation in NUC-5/PSC due to an AE possibly caused by the study drug.\n3. Liver Cirrhosis or any cirrhosis-related symptoms which in the opinion of the investigator may affect the patient's safety.\n4. History of liver transplantation or patient listed for transplantation."}, 'identificationModule': {'nctId': 'NCT06886360', 'briefTitle': 'Study with Norucholic Acid Tablets in Patients with Primary Sclerosing Cholangitis (PSC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dr. Falk Pharma GmbH'}, 'officialTitle': 'An Open-label Study of Patients with Primary Sclerosing Cholangitis (PSC) Treated with Norucholic Acid Tablets', 'orgStudyIdInfo': {'id': 'NUT-022/PSC'}, 'secondaryIdInfos': [{'id': '2024-514292-18-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'norucholic acid 1500 mg/day', 'description': '3 film-coated tablets once daily for 72 weeks containing in total norUrsodeoxycholic acid 1500 mg', 'interventionNames': ['Drug: norucholic acid']}], 'interventions': [{'name': 'norucholic acid', 'type': 'DRUG', 'description': '500 mg norucholic acid film-coated tablets; 3 tablets/day', 'armGroupLabels': ['norucholic acid 1500 mg/day']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Michael Stiess, PhD', 'role': 'CONTACT', 'email': 'zentrale@drfalkpharma.de', 'phone': '+497611514 Ext. 0'}], 'overallOfficials': [{'name': 'Michael Trauner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna, dept. of Internal Medicine III'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'It is not decided which data will be made available. A time frame cannot be indicated yet.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Falk Pharma GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}