Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-02-27 @ 10:39 AM
Study NCT ID:
NCT01756794
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2012-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of the Procedure of Early Liver Transplantation in Alcoholic Hepatitis Resisting to Medical Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006519', 'term': 'Hepatitis, Alcoholic'}, {'id': 'D008104', 'term': 'Liver Cirrhosis, Alcoholic'}], 'ancestors': [{'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008108', 'term': 'Liver Diseases, Alcoholic'}, {'id': 'D020751', 'term': 'Alcohol-Induced Disorders'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016031', 'term': 'Liver Transplantation'}], 'ancestors': [{'id': 'D016378', 'term': 'Tissue Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D016377', 'term': 'Organ Transplantation'}, {'id': 'D014180', 'term': 'Transplantation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 284}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2012-12-20', 'studyFirstSubmitQcDate': '2012-12-20', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Non-inferiority of alcohol relapse in early liver transplantation for severe alcoholic hepatitis as compared to patients transplanted for alcoholic cirrhosis.', 'timeFrame': '2 years', 'description': 'Aim is to demonstrate that alcohol relapse within the 2-year follow-up period in patients selected for early liver transplantation for severe alcoholic hepatitis is not inferior to that of patients transplanted for alcoholic cirrhosis using the 6-month sobriety period.'}], 'secondaryOutcomes': [{'measure': 'Validation of the survival benefit of transplanted patients as compared to non-transplanted patients with severe alcoholic hepatitis', 'timeFrame': '2 years', 'description': 'First secondary aim is to confirm the survival benefit of patients transplanted for severe alcoholic hepatitis as compared to patients suffering for severe alcoholic hepatitis not responding to medical treatment and not selected for early liver transplantation'}, {'measure': 'Reproducibility of an algorithm of selection for candidates to liver transplantation', 'timeFrame': '2 years', 'description': 'Second secondary aim is to evaluate the reproducibility of the algorithm for selection of candidates for liver transplantation in three centers'}, {'measure': 'Incidence of alcohol relapse', 'timeFrame': '2 years', 'description': 'Third secondary endpoint is to compare the incidence of alcohol relapse in patients selected for early transplantation for severe alcoholic hepatitis as compared to patients transplanted for alcoholic cirrhosis using the 6-month sobriety period rule'}, {'measure': 'Pattern of alcohol relapse in the two groups of transplanted patients', 'timeFrame': '2 years', 'description': 'Fourth secondary endpoint is to assess the pattern of alcohol relapse in the group of patients transplanted for severe alcoholic hepatitis to the group of patients transplanted for alcoholic cirrhosis using the 6-month sobriety rule.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Alcoholic hepatitis', 'Liver transplantation', 'Alcohol relapse', 'Alcoholic cirrhosis'], 'conditions': ['Alcoholic Hepatitis', 'Alcoholic Cirrhosis']}, 'referencesModule': {'references': [{'pmid': '35202597', 'type': 'RESULT', 'citation': 'Louvet A, Labreuche J, Moreno C, Vanlemmens C, Moirand R, Feray C, Dumortier J, Pageaux GP, Bureau C, Chermak F, Duvoux C, Thabut D, Leroy V, Carbonell N, Rolland B, Salame E, Anty R, Gournay J, Delwaide J, Silvain C, Lucidi V, Lassailly G, Dharancy S, Nguyen-Khac E, Samuel D, Duhamel A, Mathurin P; QuickTrans trial study group. Early liver transplantation for severe alcohol-related hepatitis not responding to medical treatment: a prospective controlled study. Lancet Gastroenterol Hepatol. 2022 May;7(5):416-425. doi: 10.1016/S2468-1253(21)00430-1. Epub 2022 Feb 23.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to validate a strategy of identification of patients for early liver transplantation in severe alcoholic hepatitis. In this setting, short-term survival is very low (approx. 25% at 6 months) and a pilot study has suggested (mathurin et al. N Engl J Med 2011) that liver transplantation may be an option in very carefully selected patients who did not respond to medical treatment. This selection process deserves to be confirmed in a population of greater size. We hypothesized that patients selected with this process would have a same alcohol relapse rate after liver transplantation than patients transplanted for alcoholic cirrhosis and selected using a 6-month sobriety period', 'detailedDescription': 'Non-inferiority of alcohol relapse in early liver transplantation for severe alcoholic hepatitis as compared to patients transplanted for alcoholic cirrhosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (Group A):\n\n* Age \\> 18 years\n* Maddrey score \\> 32\n* Liver biopsy confirming the diagnosis of alcoholic hepatitis\n* Non-response to medical treatment: Lille score ≥ 0.45 at day 7, or early worsening of liver function (MELD score \\> 25) despite a low Lille score (\\< 0.45)\n* Hospitalization stay \\< 1 month\n* Algorithm score ≥ 220/250.\n\nInclusion Criteria (Group B):\n\n* Age \\>18 years\n* Diagnosis of alcoholic cirrhosis\n* Alcoholic withdrawal of 6 months minimum before inscription on the transplant list\n* MELD score ≥ 15 for patients with hepatocellular carcinoma responding to Milan criteria (1 node \\< 5 cm or 3 nodes \\< 3 cm)\n* MELD score ≥ 20 preferably for patients not displaying hepatocellular carcinoma and that did not obtain an "expert" component\n* No recommendation of MELD score for patients having obtained an "expert" component\n\nNon-inclusion Criteria (Group A and B):\n\n* Bacterial or viral infection uncontrolled by medical treatment\n* Fungal or aspergillosis uncontrolled infection\n* Hepatocellular carcinoma or invasive cancer\n* Positive test for HBsAg, Positive test for HIV,Positive PCR for HCV\n* Portal thrombosis\n* Pregnancy or breast-feeding woman'}, 'identificationModule': {'nctId': 'NCT01756794', 'acronym': 'QuickTrans', 'briefTitle': 'Validation of the Procedure of Early Liver Transplantation in Alcoholic Hepatitis Resisting to Medical Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Validation of an Accelerated Procedure of Selection in Early Liver Transplantation for Severe Alcoholic Hepatitis Not Responding to Medical Treatment QuickTransHAA.', 'orgStudyIdInfo': {'id': '2010-26'}, 'secondaryIdInfos': [{'id': '2012-A00088-35', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Transplantation of alcoholic hepatitis', 'description': 'Patients of this arm will be selected for early liver transplantation for severe alcoholic hepatitis not responding to medical therapy. Selection process will be based on a specific algorithm and follow-up time will be 2 years', 'interventionNames': ['Procedure: Liver transplantation']}, {'type': 'OTHER', 'label': 'Transplantation for alcoholic cirrhosis', 'description': 'Patients of this arm will be selected for liver transplantation for alcoholic cirrhosis using an abstinence period of 6 months. Outcome of these patients will be compared to that of patients transplanted for severe alcoholic hepatitis.', 'interventionNames': ['Procedure: Liver transplantation']}], 'interventions': [{'name': 'Liver transplantation', 'type': 'PROCEDURE', 'armGroupLabels': ['Transplantation for alcoholic cirrhosis', 'Transplantation of alcoholic hepatitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B-2650', 'city': 'Antwerp', 'state': 'Edegem', 'country': 'Belgium', 'facility': 'UZA', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'ULB, Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Ghent', 'country': 'Belgium', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Liège', 'country': 'Belgium', 'facility': 'Hospital Sart Tilman', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'Univesity hospital', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '49933', 'city': 'Angers', 'country': 'France', 'facility': 'University hospital', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'University hospital', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '93143', 'city': 'Bondy', 'country': 'France', 'facility': 'Hôpital Jean Verdier (AH-HP)', 'geoPoint': {'lat': 48.9018, 'lon': 2.48931}}, {'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'University hospital', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '14000', 'city': 'Caen', 'country': 'France', 'facility': 'University hospital', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '37170', 'city': 'Chambray-lès-Tours', 'country': 'France', 'facility': 'Univesity hospital', 'geoPoint': {'lat': 47.33537, 'lon': 0.70286}}, {'zip': '92141', 'city': 'Clamart', 'country': 'France', 'facility': 'Hospital Antoine Béclère (Assistance Publique des Hôpiaux de Paris)', 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'zip': '92118', 'city': 'Clichy', 'country': 'France', 'facility': 'Hôpital Beaujon (AH-HP)', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'zip': '94000', 'city': 'Créteil', 'country': 'France', 'facility': 'Hôpital Henri Mondor (AP-HP)', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'University hospital', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'University hospital', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'University hospital', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69437', 'city': 'Lyon', 'country': 'France', 'facility': 'University hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '54500', 'city': 'Nancy', 'country': 'France', 'facility': 'University hospital', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '44035', 'city': 'Nantes', 'country': 'France', 'facility': 'University hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '06202', 'city': 'Nice', 'country': 'France', 'facility': 'University hospital', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Saint Antoine (AP-HP)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital de la Pitié-Salpétrière (AP-HP)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Cochin (AH-HP)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '33604', 'city': 'Pessac', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'University hospital', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '51092', 'city': 'Reims', 'country': 'France', 'facility': 'University hospital', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'University hospital', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '67100', 'city': 'Strasbourg', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'University hospital', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '94000', 'city': 'Villejuif', 'country': 'France', 'facility': 'Hôpital Paul Brousse (AH-HP)', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Philippe Mathurin, MD,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University hospital of Lille,'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}