Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT06767605
Status:
RECRUITING
Last Update Posted:
2025-01-10
First Post:
2025-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Spanish Registry of Autoimmune and Cholestatic Liver Diseases (ColHai)
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': 'D016738', 'term': 'Alagille Syndrome'}, {'id': 'D006933', 'term': 'Hyperbilirubinemia, Hereditary'}, {'id': 'D007566', 'term': 'Jaundice, Chronic Idiopathic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}], 'ancestors': [{'id': 'D002780', 'term': 'Cholestasis, Intrahepatic'}, {'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'}, {'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': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D007567', 'term': 'Jaundice, Neonatal'}, {'id': 'D051556', 'term': 'Hyperbilirubinemia, Neonatal'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'targetDuration': '35 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-06', 'studyFirstSubmitDate': '2025-01-06', 'studyFirstSubmitQcDate': '2025-01-06', 'lastUpdatePostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence and characteristics of autoimmune and cholestatic liver disease in Spain', 'timeFrame': '2025', 'description': 'Evaluation of clinical characteristics of autoimmune and cholestatic liver diseases'}], 'secondaryOutcomes': [{'measure': 'Development of liver-related events in autoimmune ahd cholestatic liver diseases', 'timeFrame': '2025'}, {'measure': 'Treatment of autoimmune and cholestatic liver diseases in Spain', 'timeFrame': '2016-2030'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cholestatic Genetic Diseases', 'Primary Sclerosing Cholangitis (PSC)', 'Hepatitis Autoimmune Disease', 'Primary Biliary Cholangitis (PBC)', 'PFIC tipo 1', 'PFIC tipo 2', 'PFIC tipo 3', 'PFIC tipo 4', 'BRIC tipo 1', 'BRIC tipo 2', 'Alagille syndrome', 'Rotor syndrome', 'Dubin Johnson syndrome', 'Genetic disease', 'Registry', 'cholestatic diseases'], 'conditions': ['Hepatitis Autoimmune Disease', 'Primary Biliary Cholangitis (PBC)', 'Primary Sclerosing Cholangitis (PSC)', 'Cholestatic Genetic Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of the registry is to know the status of primary biliary colgantis, autoimmune hepatitis, primary sclerosing cholagitis and genetic cholestatic diseases in Spain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a confirmed diagnosis for PBC, HAI, PSC or any genetic cholestasis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a confirmed diagnosis for PBC, HAI, PSC, genetic cholestatic disease\n\nExclusion Criteria:\n\n* Refusal to sign the informed consent for the study'}, 'identificationModule': {'nctId': 'NCT06767605', 'acronym': 'ColHai', 'briefTitle': 'Spanish Registry of Autoimmune and Cholestatic Liver Diseases (ColHai)', 'organization': {'class': 'OTHER', 'fullName': 'Asociación Española para el Estudio del Hígado'}, 'officialTitle': 'Registro Español de Enfermedades Hepáticas Colestásicas y Autoinmunes (ColHai)', 'orgStudyIdInfo': {'id': 'HCB/2016/0565'}}, 'contactsLocationsModule': {'locations': [{'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Maria Carlota Londoño Londoño', 'role': 'CONTACT', 'email': 'mlONDONO@clinic.cat', 'phoneExt': '0034915551119'}], 'facility': 'Hospital Clinic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Asociación Española para el Estudio del Hígado Asociación Espa', 'role': 'CONTACT', 'email': 'registrocolhay@gmail.com', 'phone': '0034915551119'}], 'overallOfficials': [{'name': 'Maria Carlota Londoño Londoño', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Asociación Española para el Estudio del Hígado'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asociación Española para el Estudio del Hígado', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}