Pig liver trial offers temporary lifeline for liver failure patients
NCT ID NCT07429838
First seen Jun 27, 2026 · Last updated Sep 21, 2026 · Updated 3 times
Summary
This early-stage study tests a genetically-modified pig liver used outside the body to temporarily take over liver functions for people with acute-on-chronic liver failure. About 20 adults who are not eligible for a transplant will receive this treatment for a short time. The goal is to check safety and see if it can help reduce toxins and improve liver function.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: * Male or female, age 18 to 70 years, inclusive * Not eligible for transplantation at the time of enrollment * Diagnosis of Grade 2 to 3 ACLF according to the European Association for the Study of Chronic Liver Failure (EASL-CLIF) definition and Chronic Liver Failure Consortium-organ failure score (CLIF-C-OF) ≥10 * Hepatic encephalopathy Grade 1 to 3 by West Haven Criteria * Written consent provided by participant or LAR (if participant lacks capacity, e.g., due to hepatic encephalopathy) prior to conduct of any study procedures Key Exclusion Criteria: * Prior solid organ transplant * Fulminant hepatic failure without underlying liver disease * Non-biological artificial liver extracorporeal liver support (e.g., molecular adsorbent recirculating system) or bioartificial liver support systems within 30 days prior to EGEN-5784 liver perfusion * Liver dysfunction due to trauma, or extra-hepatic cholestasis * Any uncontrolled ongoing active infection * History or active human immunodeficiency virus (HIV) infection or acute hepatitis B virus (HBV) * Chronic HBV or active hepatitis C * Diagnosis of cancer requiring active ongoing treatment, e.g., chemotherapy, radiation therapy * Severe concomitant cardiovascular disease defined as congestive heart failure Class III and IV * Significant acute or chronic pulmonary disease requiring ventilator support or diagnosed with chronic obstructive pulmonary disease Global Obstructive Lung Disease \[GOLD\] stage III or IV disorder * Active uncontrolled bleeding (i.e., any major blood loss requiring ≥2 units of pRBCs within the last 48 hours prior to screening) * Any other health condition, including illicit drug use, that would preclude participation in the study in the judgement of the PI
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Wisconsin
Madison, Wisconsin, 53792, United States
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Washington University
St Louis, Missouri, 63130, United States
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Other studies related to the condition(s) this trial covers.
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