What is the mechanism of action of this treatment?

Common treatments for liver disease include antiviral therapies and liver transplantation. Antiviral therapies reduce the viral load in conditions like hepatitis B and C, decreasing liver inflammation and preventing progression to cirrhosis or liver cancer. Liver transplantation replaces a diseased liver with a healthy donor liver, which is critical for patients with end-stage liver disease. Programs like the Liver Donor Champion Program, which focus on education and advocacy, are essential for increasing access to life-saving liver transplants.

What side effects are associated with this type of intervention?

Common treatments for liver disease, particularly antiviral therapies for hepatitis C, often have side effects such as headache, insomnia, dizziness, fatigue, nausea, and diarrhea. Specific regimens like PrOD-based therapy can cause hyperbilirubinemia, while simeprevir plus sofosbuvir may lead to photosensitivity and rash. Treatments for hepatic encephalopathy using branched-chain amino acids have shown improvements in mental recovery but also carry risks of adverse events. Overall, these treatments are generally well-tolerated, but patients should be aware of these potential side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for liver diseases, particularly those that may impact liver transplantation outcomes. For chronic hepatitis C virus (HCV) infection, direct-acting antiviral (DAA) agents such as sofosbuvir, ledipasvir, and velpatasvir have been approved and are known to improve liver function and reduce liver-related morbidity. Ursodeoxycholic acid is another FDA-approved drug used to treat primary biliary cholangitis, a chronic liver disease. These treatments are crucial as they can stabilize liver function and potentially improve the success rates of liver transplantation, aligning with the goals of the Liver Donor Champion Program to increase access to live donor liver transplantation.

What other types of research exist?

Promising alternatives to the Liver Donor Champion Program for liver disease patients in 2024 include: 1) Advanced pharmacologic treatments such as new antiviral therapies and immunomodulators that improve liver function and delay the need for transplantation. 2) Regenerative medicine approaches, including stem cell therapy and bioengineered liver tissues, which aim to repair or replace damaged liver tissue. 3) Enhanced organ preservation techniques and ex vivo liver perfusion systems that improve the viability and availability of donor livers. 4) Telemedicine and digital health platforms that provide remote monitoring and management of liver disease, improving patient outcomes and access to care.

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Live Donor Champion Program for Liver Disease (LLDC Trial)

N/A

Waitlist Available

Led By Elizabeth A King, MD PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Mentally capable of providing informed consent

Active candidate on the liver transplant waitlist

Must not have

Age less than 18 years old

Non-English speaking

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 6 months of enrollment

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a program that trains someone close to liver transplant candidates to help them find living donors. It aims to reduce waiting times and improve outcomes by providing education and advocacy training.

Who is the study for?

This trial is for adults over 18 who speak English, are mentally able to consent, and are on the liver transplant waitlist without any current living donors. It's not for those under 18, non-English speakers, anyone with potential live donors already identified, or patients who have had a previous liver transplant or need multiple organs.

What is being tested?

The study tests an educational and advocacy program called the Liver Live Donor Champion Program. This pilot will evaluate two versions of the program to see how well they help expand access to live donor liver transplants by training 'Live Donor Champions' alongside transplant candidates.

What are the potential side effects?

Since this is an educational and advocacy training program rather than a medical treatment, there are no direct physical side effects associated with participating in this clinical trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am mentally capable of understanding and agreeing to the trial's procedures.

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I am on the waiting list for a liver transplant.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I do not speak English.

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I have had a liver transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 6 months of enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 6 months of enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 6 months of enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Live Donor Inquiries

Live Donor Liver Transplantation

Secondary study objectives

Comfort initiating conversations

Feasibility - Implementation Outcome

Knowledge of live donation and liver transplantation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Liver Live Donor ChampionExperimental Treatment1 Intervention

The Liver Live Donor Champion program (LLDC) is the sole educational intervention for this trial. LLDC consists of 2 or 3 monthly sessions (depending on cohort) of approximately 2 or 3 hours each. Each LLDC session is led by a transplant physician or clinical coordinator. The sessions incorporate formal didactics, active-participant learning, personal stories, moderated group discussions, role-playing, and other skill-building exercises. LLDC session topics are as follows: 1) education about End-Stage Liver Disease (ESLD), liver transplantation, and living donation 2) communication skills building 3) Exploring social networks 4) sharing successful donor and recipient stories 5) surgeon and hepatologist panel 6) Program Recap.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for liver disease include antiviral therapies and liver transplantation. Antiviral therapies reduce the viral load in conditions like hepatitis B and C, decreasing liver inflammation and preventing progression to cirrhosis or liver cancer. Liver transplantation replaces a diseased liver with a healthy donor liver, which is critical for patients with end-stage liver disease. Programs like the Liver Donor Champion Program, which focus on education and advocacy, are essential for increasing access to life-saving liver transplants.