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Plasma Exchange for Liver Failure (APACHE Trial)
APACHE Trial 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.
APACHE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowAPACHE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.APACHE Trial Design
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Who is running the clinical trial?
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- My liver failure condition improved or worsened during the screening period.I have severe lung disease (GOLD stage III or IV).If I'm unable to consent, a family member or legal representative will do so for me.I have had a liver transplant.My liver failure is classified as ACLF-1a or ACLF-3b.I have had acute-on-chronic liver failure for over 10 days.I am in septic shock and need strong medication to maintain my blood pressure.I have chronic kidney failure and am on hemodialysis.I am on blood thinners, but low molecular weight heparin for clot prevention is okay.I am between 18 and 79 years old with liver cirrhosis.I have sudden liver failure without long-term liver damage.I have an active infection and have been on antibiotics for less than a day.I have severe breathing problems with low oxygen levels.I have not had any active or recent bleeding, or it has been controlled for more than 48 hours.My cancer is advanced or has spread, but excludes certain skin, breast, or prostate cancers if they are under control.I am not pregnant, breastfeeding, and if I can have children, I agree to use effective birth control.I have been diagnosed with severe muscle disease.I am HIV positive or show symptoms of HIV.I currently have COVID-19, am recovering, or show symptoms of it.I have severe chronic heart failure.
- Group 1: SMT+ PE-A 5%
- Group 2: Standard Medical Treatment (SMT)
- 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.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does the age limit for this clinical trial extend beyond 40 years old?
"This trial is for adults aged 18 to 79. If you are a minor or senior, there are 11 other trials you may be eligible for."
What do prior research papers say about SMT + PE-A 5%?
"Originally, SMT + PE-A 5% was studied in 2007 at Herbert Irving Pavillion 11th Floor. As of now, there are a total of 180 completed trials. Out of these, 139 are actively recruiting patients with a high number of these studies concentrated in Birmingham, Alabama."
Are there any open slots for participants in this trial?
"That is correct. The clinicaltrials.gov website contains information that this trial is still recruiting participants. The trial was created on 21 February 2019 and was last edited on 30 September 2022. There is a need for 380 participants across 10 sites."
How many people are signing up to participate in this research?
"Yes, this is an ongoing recruitment according to the information provided on clinicaltrials.gov. The posting date was February 21st, 2019 and the most recent edit was on September 30th, 2022. They are looking for 380 participants total and have 10 different recruitment sites."
Has the FDA given their okay to SMT + PE-A 5%?
"Although this is only a Phase 3 trial, SMT + PE-A 5% has undergone enough testing to be considered safe."
How many hospitals are a part of this research project?
"Currently, this trial is ongoing at 10 research centres, some of which are located in major cities such as Birmingham, Milwaukee and Philadelphia. To reduce the participant's burden, it is best to choose a location nearest to you."
What medical conditions does SMT + PE-A 5% help to manage?
"SMT + PE-A 5% is an effective medical intervention for peritonitis, liver failure, acute, and prophylaxis of hypovolemia."
If I enroll, am I able to complete the requirements of this study?
"The prerequisites for admission into this clinical trial are that potential patients must have acute-on-chronic liver failure and be between 18 and 79 years old. In total, 380 individuals can take part in this experiment."
To the best of your knowledge, does this kind of research exist?
"SMT + PE-A 5% has been under clinical study since 2007. The first trial was sponsored by Celgene Corporation and took place that same year. After the initial trial, which included 47 patients, SMT + PE-A 5% received Phase 1 & 2 drug approval. There are now 139 active trials for SMT + PE-A 5% being conducted in 918 cities across 33 countries."
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