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Albumin Dialysis

Group 1: Standard Medical Therapy + MARS for Liver Failure

N/A
Waitlist Available
Led By Tarek Hassanein, MD
Research Sponsored by Baxter Healthcare Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within the five-day treatment period
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Liver Failure
  • Hepatic Encephalopathy
  • Non-invasive Indices to Predict Hepatic Fibrosis in BA Patients.
  • Chronic Viral Hepatitis
  • Encephalopathy
  • Chronic Hepatitis
  • Liver Cirrhosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within the five-day treatment period
This trial's timeline: 3 weeks for screening, Varies for treatment, and within the five-day treatment period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Two-point reduction in HE score from the randomization grade

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group 1: Standard Medical Therapy + MARSExperimental Treatment2 Interventions
Patients who were randomized to Group 1 received daily MARS treatments in addition to Standard Medical Therapy for 5 consecutive days.
Group II: Group 2: Standard Medical Therapy OnlyActive Control1 Intervention
Patients who were randomized to Group 2 received standard medical treatment only.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MARS
2000
N/A
~70
Standard Medical Therapy
2018
Completed Phase 4
~830

Find a Location

Who is running the clinical trial?

Baxter Healthcare CorporationLead Sponsor
321 Previous Clinical Trials
202,521 Total Patients Enrolled
1 Trials studying Liver Failure
59 Patients Enrolled for Liver Failure
Gambro Renal Products, Inc.Industry Sponsor
16 Previous Clinical Trials
1,377 Total Patients Enrolled
Tarek Hassanein, MDPrincipal InvestigatorUniversity of California San Diego Medical Center (UCSD)
4 Previous Clinical Trials
310 Total Patients Enrolled
~3 spots leftby Nov 2025
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