3000 Participants Needed

Liver Transplantation for Liver Failure

(CHANCE Trial)

Recruiting at 104 trial locations
AB
Overseen ByAnna Bosch
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: European Foundation for Study of Chronic Liver Failure
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores liver transplantation as a treatment for individuals with severe liver failure and cirrhosis. It seeks to identify the best methods to improve survival rates after a liver transplant, with a focus on living-donor transplants. The trial includes three groups: those on the transplant list with severe liver failure, those on the list with poor liver function, and those assessed but not listed for transplantation. It suits individuals diagnosed with cirrhosis who have been hospitalized for liver issues and are considering or have been considered for a liver transplant. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team to get a clear answer.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that liver transplants can be a viable option for individuals with serious liver conditions, such as acute-on-chronic liver failure (ACLF). Studies have found that 80% to 90% of these patients survive at least one year post-transplant, indicating that most handle the procedure well.

However, the success of a liver transplant often depends on the patient's pre-surgery health. For instance, those with multiple organ failures tend to have a poorer prognosis. Although the surgery is a major operation, most patients do not encounter serious complications afterward.

In summary, liver transplants are generally safe for many patients and can significantly improve survival chances. However, individual health conditions can influence the outcomes.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores liver transplantation for patients with severe acute-on-chronic liver failure (ACLF), a condition that is typically managed with supportive care and medications aimed at controlling symptoms and complications. Unlike standard care, which often focuses on stabilizing patients, liver transplantation offers a potential long-term solution by replacing the damaged liver with a healthy one. The trial investigates the outcomes for different patient groups, including those with severe liver failure and those at high risk but not listed for transplantation, potentially broadening the criteria for who might benefit from a transplant. This could lead to more personalized treatment approaches and improve survival rates for patients with this challenging condition.

What is the effectiveness track record for liver transplantation in managing ACLF?

Studies have shown that liver transplantation (LT) can be effective for patients with acute-on-chronic liver failure (ACLF). Research indicates that 81% of patients who received a liver transplant survived for at least one year, compared to none who did not receive a transplant. In this trial, participants are divided into three groups: Group 1 includes patients listed for liver transplantation with ACLF-2 or 3, Group 2 includes those listed with decompensated cirrhosis without ACLF-2 or 3, and Group 3 includes patients with ACLF-2 or 3 who are assessed but not listed for transplantation. Some studies mention challenges, such as the need for more resources and lower survival rates in certain groups. Despite these challenges, liver transplantation remains an important option for treating ACLF. Results can vary, and the success of a liver transplant may depend on factors like the patient's health and the timing of the transplant.678910

Are You a Good Fit for This Trial?

Inclusion Criteria

2. Subjects with diagnosis of liver cirrhosis (based on clinical, laboratory, endoscopic, and ultrasonographic features or on histology).
Group 1: patients listed for liver transplantation with ACLF-2 or 3 at the time of listing or developing ACLF 2-3 while on the waiting list.
Group 2: patients listed for liver transplantation with decompensated cirrhosis without ACLF-2 or 3 and poor liver function (MELD>20) at the time of listing.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Transplantation

Participants undergo liver transplantation if eligible, with a focus on comparing outcomes between different patient groups

Immediate

Follow-up

Participants are monitored for graft and patient survival rates, as well as quality of life post-transplantation

1 year

Waiting List Monitoring

Participants are monitored while on the waiting list for liver transplantation, assessing outcomes and predictive factors

Variable

What Are the Treatments Tested in This Trial?

Interventions

  • Liver Transplantation

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Group 3Experimental Treatment1 Intervention
Group II: Group 2Experimental Treatment1 Intervention
Group III: Group 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

European Foundation for Study of Chronic Liver Failure

Lead Sponsor

Trials
4
Recruited
3,400+

Citations

Liver Transplantation in the Context of Acute-On-Chronic ...

The results of this study confirmed initial findings with a 1-year survival rate of 81% among transplanted patients, compared to 0% in those who ...

Review Liver transplantation for acute-on-chronic liver failure

This Review discusses liver transplantation as a treatment option for ACLF, and how effective delivery will require a shift in clinician practice.

Study Details | NCT04613921 | Liver Transplantation in ...

The aim of this study is to compare 1-year graft and patient survival rates after liver transplantation (LT) in patients with ACLF-2 or 3 at the time of LT, ...

Liver transplantation for critically ill patients with acute on ...

Longterm outcomes of patients undergoing liver transplantation for acute-on-chronic liver failure. Liver Transplant. 2020;26(12):1594–1602 ...

Outcomes of Liver Transplant Recipients With Acute-on- ...

Patients with ACLF undergoing LT have significantly higher resource utilization, inferior graft survival and patient survival, and renal dysfunction at 1 year.

Acute-on-Chronic Liver Failure—Current Management and ...

Longterm Outcomes of Patients Undergoing Liver Transplantation for Acute-on-Chronic Liver Failure. Liver Transplant. 2020;26:1594–1602. doi ...

Liver Transplantation in Patients With CirrHosis and ...

Management of ACLF is mainly supportive. The poor outcomes lead physicians to consider liver transplantation as an option, even if controversial.

Assessment of liver transplantation eligibility for ACLF ...

Patients with ACLF seem to have a poorer prognosis and can be classified in 3 groups, based on organ failures' number. Grade 1 is defined by kidney failure ( ...

Liver transplantation consideration and evaluation

This review paper investigates the role of liver transplantation in the setting of ACLF. In light of recent evidence, MELD score is not the perfect model in ...

Liver transplantation for acute liver failure and acute-on- ...

Survival post-LT for ALF and ACLF ranges between 90% and 95% and 80% and 90% at 1 year, futility criteria have been described in both ALF and ACLF where organ ...