Liver Diseases, AlcoholicNCT04234139
Cohort/Ethics Study of Patients With Severe Alcoholic Hepatitis Undergoing Early Liver Transplantation
An observational study of Liver Diseases, Alcoholic and Alcohol-Related Disorders, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study is to develop a clinical understanding of early liver transplantation (ELT) for patients with severe alcoholic hepatitis (SAH) and identify the public's opinion regarding this practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Diseases, Alcoholic, Alcohol-Related Disorders, Transplant; Failure, Liver
- What is being tested?
- liver transplant
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2020to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Severe Alcoholic Hepatitis patients listed for liver transplatation at Johns Hopkins Hospital and patients undergoing liver transplantation at Johns Hopkins Hospital for Alcoholic Liver Disease
Who may be able to join
- Patients with Severe Alcoholic Hepatitis (SAH) listed for liver transplantation at Johns Hopkins Hospital (JHH), have not been sober for at least 6 months at time of waitlisting, and are at least 18 years old.
- Patients 18 years or older undergoing liver transplantation at JHH for alcoholic liver disease and were sober for at least 6 months prior to transplantation.
Who cannot join
- Non-SAH patients listed for liver transplantation at JHH and patients who have been sober for at least 6 months at the time of waitlisting.
- Patients who do not meet inclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this study is to develop a clinical understanding of early liver transplantation (ELT) for patients with severe alcoholic hepatitis (SAH) and identify the public's opinion regarding this practice.
Read the detailed description
The research study is designed to improve the investigators' understanding of early liver transplantation for patients with severe alcoholic hepatitis. The goal of this research is twofold:
- Establish a knowledge base necessary for appropriate liver transplant candidate selection by quantifying post-ELT mortality for SAH and compare to outcomes to liver transplantation for other indications
- Develop an ethical framework for implementation of these transplants for SAH based on the opinions of healthcare providers and the general public.
- Conditions
- Liver Diseases, Alcoholic, Alcohol-Related Disorders, Transplant; Failure, Liver, Transplant; Complication, Rejection, Liver Diseases, Hepatitis, Alcoholic
- Being tested
- liver transplant
- Keywords
- liver transplant, alcoholic liver disease
- Medical subject headings
- Liver Diseases, Alcoholic, Alcohol-Related Disorders, Rejection, Psychology, Liver Diseases, Hepatitis, Alcoholic, Alcohol-Induced Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liver transplantProcedure or surgery
solid organ transplant
| Study group | Role | What they receive |
|---|---|---|
| Retrospective Cohort | Early Liver Transplantation (ELT) for patients who presented with Severe Alcoholic Hepatitis (SAH) Receives: Procedure: liver transplant | |
| Prospective Cohort 1 | Early Liver Transplantation (ELT) for patients who present with Severe Alcoholic Hepatitis (SAH) Receives: Procedure: liver transplant | |
| Prospective Cohort 2 | Orthotopic Liver Transplantation (OLT) in patient who present with Alcoholic Liver Disease (ALD) Receives: Procedure: liver transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who survived within 1 year post-transplant
Post-transplant survival within one year of the surgical procedure.
Measured: 1 years
Secondary outcomes (1)
Number of participants who self-report or have biochemically measured alcohol recidivism or relapse within 1 year post-transplant
Self-reported or biochemically measured alcohol recidivism or relapse.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start1 Apr 2020
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver Diseases, AlcoholicStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Andrew M Cameron, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234139
- Sponsor's protocol ID
- IRB00154881
- Other IDs
- P50AA027054
- Status last verified
- Dec 2025
- First submitted
- 15 Jan 2020
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee BP, Chen PH, Haugen C, Hernaez R, Gurakar A, Philosophe B, Dagher N, Moore SA, Li Z, Cameron AM. Three-year Results of a Pilot Program in Early Liver Transplantation for Severe Alcoholic Hepatitis. Ann Surg. 2017 Jan;265(1):20-29. doi: 10.1097/SLA.0000000000001831.
PubMed 27280501Weeks SR, Sun Z, McCaul ME, Zhu H, Anders RA, Philosophe B, Ottmann SE, Garonzik Wang JM, Gurakar AO, Cameron AM. Liver Transplantation for Severe Alcoholic Hepatitis, Updated Lessons from the World's Largest Series. J Am Coll Surg. 2018 Apr;226(4):549-557. doi: 10.1016/j.jamcollsurg.2017.12.044. Epub 2018 Feb 2.
PubMed 29409981
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort/Ethics Study of Patients With Severe Alcoholic Hepatitis Undergoing Early Liver Transplantation
- ClinicalTrials.gov ID
- NCT04234139
- Acronym / sponsor ID
- IRB00154881
- Conditions
- Liver Diseases, Alcoholic, Alcohol-Related Disorders, Transplant; Failure, Liver, Transplant; Complication, Rejection, Liver Diseases, Hepatitis, Alcoholic
- Keywords
- liver transplant, alcoholic liver disease
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 21 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop a clinical understanding of early liver transplantation (ELT) for patients with severe alcoholic hepatitis (SAH) and identify the public's opinion regarding this practice.
Detailed description
The research study is designed to improve the investigators' understanding of early liver transplantation for patients with severe alcoholic hepatitis. The goal of this research is twofold:
- Establish a knowledge base necessary for appropriate liver transplant candidate selection by quantifying post-ELT mortality for SAH and compare to outcomes to liver transplantation for other indications
- Develop an ethical framework for implementation of these transplants for SAH based on the opinions of healthcare providers and the general public.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Retrospective Cohort | – | Procedure: liver transplantEarly Liver Transplantation (ELT) for patients who presented with Severe Alcoholic Hepatitis (SAH) |
| Prospective Cohort 1 | – | Procedure: liver transplantEarly Liver Transplantation (ELT) for patients who present with Severe Alcoholic Hepatitis (SAH) |
| Prospective Cohort 2 | – | Procedure: liver transplantOrthotopic Liver Transplantation (OLT) in patient who present with Alcoholic Liver Disease (ALD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Severe Alcoholic Hepatitis patients listed for liver transplatation at Johns Hopkins Hospital and patients undergoing liver transplantation at Johns Hopkins Hospital for Alcoholic Liver Disease
Key inclusion criteria (2 listed)
- Patients with Severe Alcoholic Hepatitis (SAH) listed for liver transplantation at Johns Hopkins Hospital (JHH), have not been sober for at least 6 months at time of waitlisting, and are at least 18 years old.
- Patients 18 years or older undergoing liver transplantation at JHH for alcoholic liver disease and were sober for at least 6 months prior to transplantation.
Key exclusion criteria (2 listed)
- Non-SAH patients listed for liver transplantation at JHH and patients who have been sober for at least 6 months at the time of waitlisting.
- Patients who do not meet inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liver transplantsolid organ transplant | Procedure or surgery | Prospective Cohort 1, Prospective Cohort 2, Retrospective Cohort |
Primary outcome
Number of participants who survived within 1 year post-transplant
Time frame: 1 years
Post-transplant survival within one year of the surgical procedure.
1 secondary outcome
Number of participants who self-report or have biochemically measured alcohol recidivism or relapse within 1 year post-transplant
Time frame: 1 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Background: PubMed 27280501Lee BP, Chen PH, Haugen C, Hernaez R, Gurakar A, Philosophe B, Dagher N, Moore SA, Li Z, Cameron AM. Three-year Results of a Pilot Program in Early Liver Transplantation for Severe Alcoholic Hepatitis. Ann Surg. 2017 Jan;265(1):20-29. doi: 10.1097/SLA.0000000000001831.
- Background: PubMed 29409981Weeks SR, Sun Z, McCaul ME, Zhu H, Anders RA, Philosophe B, Ottmann SE, Garonzik Wang JM, Gurakar AO, Cameron AM. Liver Transplantation for Severe Alcoholic Hepatitis, Updated Lessons from the World's Largest Series. J Am Coll Surg. 2018 Apr;226(4):549-557. doi: 10.1016/j.jamcollsurg.2017.12.044. Epub 2018 Feb 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew M Cameron, MD, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases, Alcoholic and Alcohol-Related Disorders, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who survived within 1 year post-transplant (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04234139, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.