Efficacy of Albumin Dialysis to Treat Patients With Hepatic Encephalopathy Using The Molecular Adsorbent Recirculating System (MARS)

NCT00287235 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-03-03

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

MARS

DRUG

Standard Medical Therapy

Sponsors & Collaborators

  • Gambro Renal Products, Inc.

    collaborator INDUSTRY
  • Baxter Healthcare Corporation

    collaborator INDUSTRY
  • Vantive Health LLC

    lead INDUSTRY

Principal Investigators

  • Tarek Hassanein, MD · University of California San Diego Medical Center (UCSD)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-09-30
Primary Completion
2003-11-30
Completion
2004-04-30

Countries

  • United States
  • Belgium
  • Denmark

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00287235 on ClinicalTrials.gov