Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2025-12-25 @ 7:49 PM
Study NCT ID:
NCT00287235
Status:
COMPLETED
Last Update Posted:
2025-03-03
First Post:
2006-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Albumin Dialysis to Treat Patients With Hepatic Encephalopathy Using The Molecular Adsorbent Recirculating System (MARS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006501', 'term': 'Hepatic Encephalopathy'}, {'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D058625', 'term': 'End Stage Liver Disease'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2004-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-26', 'studyFirstSubmitDate': '2006-02-02', 'studyFirstSubmitQcDate': '2006-02-02', 'lastUpdatePostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Two-point reduction in HE score from the randomization grade', 'timeFrame': 'Within the five-day treatment period', 'description': 'The primary outcome measure was a two-point reduction in HE score from the the randomization grade (i.e. Grade 4 improved to at least Grade 2 and Grade 3 improved to at least Grade 1). Two summary statistics were used in the analysis: 1) The proportion of HE readings within the five-day treatment period showing an improvement of at least two points over baseline 2) The time from admission to the first two-point improvement in HE score.'}], 'secondaryOutcomes': [{'measure': 'Magnitude, duration and time of improvement in Hepatic Encephalopathy', 'timeFrame': 'Within the five-day treatment period'}, {'measure': 'Cognitive function and functional status of patients', 'timeFrame': 'Within the five-day treatment period'}, {'measure': 'Renal function, serum bilirubin, bile acids, prothrombin activity and the hemodynamics of patients with Hepatic Encephalopathy', 'timeFrame': 'Within the five-day treatment period'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hepatic Encephalopathy', 'End Stage Liver Disease', 'Cirrhosis', 'MARS', 'Albumin Dialysis'], 'conditions': ['Hepatic Encephalopathy', 'Liver Failure', 'Hepatitis, Chronic', 'Liver Cirrhosis']}, 'referencesModule': {'references': [{'pmid': '17975845', 'type': 'RESULT', 'citation': 'Hassanein TI, Tofteng F, Brown RS Jr, McGuire B, Lynch P, Mehta R, Larsen FS, Gornbein J, Stange J, Blei AT. Randomized controlled study of extracorporeal albumin dialysis for hepatic encephalopathy in advanced cirrhosis. Hepatology. 2007 Dec;46(6):1853-62. doi: 10.1002/hep.21930.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study was to compare the efficacy, safety and tolerability of Extracorporeal Albumin Dialysis (ECAD) using the Molecular Adsorbent Recirculating System (MARS®) device in improving severe HE by 2 grades compared to Standard Medical Therapy (SMT) in patients with chronic End Stage Liver Disease (ESLD) during a 5 day study period.', 'detailedDescription': 'The trial was a two-group unblinded multicenter clinical trial. Patients were randomized to receive either SMT or SMT plus five days MARS® treatment. The trial design called for patients to receive a baseline hepatic encephalopathy (HE) assessment on admission, and at 12-hour intervals, giving 10 HE measurements during treatment using a refinement / adaptation of the Conn West Haven HE Criteria HE scoring system'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Signed written informed consent by patient or patient's legally appointed representative\n2. Be at least 18 years of age; male or female\n3. Have chronic end stage liver disease with worsening Hepatic Encephalopathy (Grades 3,4).\n\nExclusion Criteria:\n\n1. Clinically significant bleeding from gastrointestinal or other site within the last 24 hours and requires 2 or more units of blood to maintain a stable hemoglobin level\n2. Hemodynamically unstable or on vasopressor agents for blood pressure support (except for renal-dosed dopamine)\n3. On acute or chronic hemodialysis or continuous renal replacement therapy (CRRT)\n4. Pregnancy\n5. Inability to obtain informed consent\n6. Uncontrolled sepsis as defined by hemodynamic instability\n7. Post-liver transplant\n8. Fulminant hepatic failure\n9. Irreversible brain damage as indicated by the neurologic examination and CT imaging\n10. Endocarditis\n11. Pulmonary edema\n12. Massive aspiration pneumonia secondary to Hepatic Encephalopathy\n13. Active alcohol consumption as determined by a positive blood ethanol level on enrollment/admission\n14. Acute main portal vein thrombosis in patients with Hepatocellular Carcinoma"}, 'identificationModule': {'nctId': 'NCT00287235', 'briefTitle': 'Efficacy of Albumin Dialysis to Treat Patients With Hepatic Encephalopathy Using The Molecular Adsorbent Recirculating System (MARS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vantive Health LLC'}, 'officialTitle': 'A Prospective, Controlled Study Of The Clinical Efficacy Of Albumin Dialysis Using The Molecular Adsorbent Recirculating System (MARS®) For The Treatment Of Patients With Hepatic Encephalopathy', 'orgStudyIdInfo': {'id': 'MARS HE Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: Standard Medical Therapy + MARS', 'description': 'Patients who were randomized to Group 1 received daily MARS treatments in addition to Standard Medical Therapy for 5 consecutive days.', 'interventionNames': ['Device: MARS', 'Drug: Standard Medical Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2: Standard Medical Therapy Only', 'description': 'Patients who were randomized to Group 2 received standard medical treatment only.', 'interventionNames': ['Drug: Standard Medical Therapy']}], 'interventions': [{'name': 'MARS', 'type': 'DEVICE', 'otherNames': ['ECAD', 'Extracorporeal Albumin Dialysis'], 'armGroupLabels': ['Group 1: Standard Medical Therapy + MARS']}, {'name': 'Standard Medical Therapy', 'type': 'DRUG', 'otherNames': ['SMT'], 'armGroupLabels': ['Group 1: Standard Medical Therapy + MARS', 'Group 2: Standard Medical Therapy Only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92103-8707', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia-Presbyterian Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'University Hospital of Copenhagen, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Tarek Hassanein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California San Diego Medical Center (UCSD)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vantive Health LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Gambro Renal Products, Inc.', 'class': 'INDUSTRY'}, {'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}