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Plasma Exchange

Plasma Exchange for Liver Failure (APACHE Trial)

Phase 3
Recruiting
Research Sponsored by Grifols Therapeutics LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female cirrhotic subjects between 18 and 79 years of age
Be older than 18 years old
Must not have
Subjects with severe pulmonary disease (Global Obstructive Lung Disease [GOLD] stage III or IV)
Subjects with previous liver transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 90
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial will test whether plasma exchange using human serum albumin 5% can improve outcomes for people with acute-on-chronic liver failure who are at high risk of hospital mortality.

Who is the study for?
This trial is for men and women aged 18-79 with cirrhosis experiencing acute-on-chronic liver failure (ACLF) grades 1b, 2, or 3a. Participants must be able to consent or have a representative who can. Exclusions include severe infections, respiratory failure, certain cancers, pregnancy, drug addiction (except alcohol/marijuana), recent participation in other trials, and various severe health conditions.
What is being tested?
The study compares standard medical treatment (SMT) alone versus SMT combined with plasma exchange using human serum albumin 5% (PE-A 5%) in patients with ACLF. It's randomized and open-label; participants will receive treatments for up to 17 days based on their condition's progression followed by a three-month follow-up.
What are the potential side effects?
Potential side effects of the plasma exchange procedure may include allergic reactions to the albumin solution, low calcium levels due to fluid replacement therapy leading to muscle cramps or tingling sensations, bleeding from where the catheter was inserted into a vein or artery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 79 years old with liver cirrhosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe lung disease (GOLD stage III or IV).
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I have had a liver transplant.
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My liver failure is classified as ACLF-1a or ACLF-3b.
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I am in septic shock and need strong medication to maintain my blood pressure.
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I have chronic kidney failure and am on hemodialysis.
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I am on blood thinners, but low molecular weight heparin for clot prevention is okay.
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I have sudden liver failure without long-term liver damage.
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I have an active infection and have been on antibiotics for less than a day.
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I have severe breathing problems with low oxygen levels.
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I am not pregnant, breastfeeding, and if I can have children, I agree to use effective birth control.
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I have been diagnosed with severe muscle disease.
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I am HIV positive or show symptoms of HIV.
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I have severe chronic heart failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 90
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 90 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to death through Day 90
Secondary study objectives
Time to death through Day 28
Time to transplant or death through Day 90

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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: SMT+ PE-A 5%Experimental Treatment1 Intervention
PE-A 5% will be performed using 5% albumin (Albutein 5%) as the main replacement fluid administered intravenously.
Group II: Standard Medical Treatment (SMT)Active Control1 Intervention
Standard medical treatment (SMT) will be administered according to institution standards.

Find a Location

Who is running the clinical trial?

Instituto Grifols, S.A.Industry Sponsor
29 Previous Clinical Trials
3,825 Total Patients Enrolled
1 Trials studying Liver Failure
12 Patients Enrolled for Liver Failure
Grifols Therapeutics LLCLead Sponsor
58 Previous Clinical Trials
5,728 Total Patients Enrolled

Media Library

PE-A 5% (Plasma Exchange) Clinical Trial Eligibility Overview. Trial Name: NCT03702920 — Phase 3
Liver Failure Research Study Groups: SMT+ PE-A 5%, Standard Medical Treatment (SMT)
Liver Failure Clinical Trial 2023: PE-A 5% Highlights & Side Effects. Trial Name: NCT03702920 — Phase 3
PE-A 5% (Plasma Exchange) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03702920 — Phase 3
~92 spots leftby Oct 2026
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