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Sponsors and Collaborators: |
University of California, San Diego Sponsor of study was Teraklin, AG and Gambro, Inc. |
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Information provided by: | University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT00287235 |
This purpose of this study is to determine the safety and efficacy of albumin dialysis using the MARS device in improving severe Hepatic Encephalopathy compared to standard medical therapy in patients with chornic ESLD.
Condition | Intervention | Phase |
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Hepatic Encephalopathy Liver Failure Hepatitis, Chronic Liver Cirrhosis |
Device: Molecular Adsorent Recirculating System (MARS) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Controlled Study Evaluating Extracorporeal Albumin Dialysis Using the Molecular Adsorbent Recirculating System (MARS) for Patients With Cirrhosis and Hepatic Encephalopathy |
Estimated Enrollment: | 70 |
Study Start Date: | August 2000 |
Estimated Study Completion Date: | April 2004 |
The primary objective of the study was to compare the efficacy, safety and tolerability of ECAD using the MARS device in improving severe HE by 2 grades compared to standard medical therapy in patients with chronic ESLD during the 5 day study period. The secondary objectives were to assess the time to improvement of HE by 2 grades and the effects of ECAD on laboratory parameters.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
University of Alabama | |
Birmingham, Alabama, United States | |
United States, California | |
University of California, San Diego | |
San Diego, California, United States, 92103-8707 | |
United States, Illinois | |
Northwestern University | |
Chicago, Illinois, United States | |
United States, Michigan | |
University of Michigan | |
Ann Arbor, Michigan, United States | |
United States, New York | |
Columbia University | |
New York, New York, United States | |
United States, Virginia | |
University of Virginia | |
Charlottesville, Virginia, United States | |
Belgium | |
UZ Gasthuisberg | |
Leuven, Belgium | |
Denmark | |
Rigshospitalet Copenhagen | |
Copenhagen, Denmark |
Study ID Numbers: | MARS HE Study |
Study First Received: | February 2, 2006 |
Last Updated: | February 2, 2006 |
ClinicalTrials.gov Identifier: | NCT00287235 |
Health Authority: | United States: Food and Drug Administration |
Hepatic Encephalopathy End Stage Liver Disease Cirrhosis MARS Albumin Dialysis |
Liver Diseases Neurotoxicity Syndromes Hepatitis, Chronic Fibrosis Brain Damage, Chronic Disorders of Environmental Origin Liver Cirrhosis Brain Diseases Signs and Symptoms Mental Disorders Brain Injuries Dementia Neurobehavioral Manifestations Hepatic Insufficiency Delirium |
Liver Failure Metabolic Diseases Neurotoxicity syndromes Poisoning Central Nervous System Diseases Confusion Encephalitis Cognition Disorders Virus Diseases Hepatitis Hepatic Encephalopathy Digestive System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Central Nervous System Infections Neurologic Manifestations |
Pathologic Processes Nervous System Diseases Central Nervous System Viral Diseases |