AuthorisedPhase I and Phase II (Integrated)- OtherInterventional

NEurotrophins MImetic compound for modulation of ischemia/reperfusion damage in Liver transplantation with Extended criteria Donors, a phase I/II explorative, open label, controlled, randomized study

This research study is testing a new medicine designed to protect the liver during transplant surgery. When a new liver is transplanted, especially from donors whose livers might be slightly less healthy (called 'extended criteria donors'), they can sometimes be damaged by the surgery itself. This new medicine aims to reduce this damage. This early-stage study, called a Phase I/II, will involve people aged 18 and over who are having a liver transplant. Researchers want to see if the medicine is safe and if it helps the transplanted liver to work well. Some participants will receive the new medicine, and others will receive standard care, allowing doctors to compare the results. It's an important step in trying to improve liver transplant outcomes.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Mimetech S.r.l.

Enrolment target

Start

13 Mar 2024

Liver Transplant

What is this study about?

This study is about making liver transplants safer and more successful, especially for people receiving a liver from a specific type of donor. When someone needs a liver transplant, they receive a liver from a donor. Sometimes, to help more people get the life-saving transplants they need, doctors use livers from 'extended criteria donors.' This means the liver might not be as perfectly healthy as a standard donor liver, perhaps because of the donor's age or other factors. These livers can be more vulnerable to damage during the transplant process.

During the transplant operation, when the new liver is connected, it experiences something called 'ischemia/reperfusion damage.' This basically means damage that happens when the blood flow is stopped and then restarted. This new experimental medicine is designed to protect the liver cells from this type of damage.

By taking part in this study, you would be helping doctors understand if this new medicine can reduce the damage to transplanted livers. The ultimate goal is to improve how well the new liver works and to help people recover better after a liver transplant, particularly when using livers from extended criteria donors. This is an early-stage study, so doctors are looking to see if the medicine is safe and shows promise.

Key takeaways

Tests a new medicine for liver transplant patients.
Aims to protect livers from less healthy (extended criteria) donors.
Is an early-stage study focusing on safety and initial effectiveness.
Participation involves receiving the study medicine or standard care.
You can withdraw from the study at any time.
Your transplant team can tell you if you might be eligible.

Who may be eligible?

This study is for adults aged 18 and older. Both men and women can take part. To be eligible, you must be a patient who is going to have a liver transplant using a liver from an 'extended criteria donor.' Your transplant team will be able to explain if your donor liver is considered to be of this type.

There will be other specific health requirements that the study doctors will go through with you. These are in place to make sure that the study is safe for you and that the results of the research are as clear as possible. Things like your general health, other medical conditions, or medicines you are taking might affect whether you can join.

If you are interested, your doctor or transplant team will discuss all the details with you and check if you meet all the necessary criteria to be considered for the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you scheduled to have a liver transplant?
Has your transplant team indicated your donor liver might be from an 'extended criteria donor'?
Are you able to attend follow-up appointments after your transplant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new study medicine as part of your liver transplant procedure. Some people in the study might receive the new medicine, while others will receive the usual care, as is common in research studies to compare treatments. You wouldn't know which group you are in, and neither would your doctors, to ensure fairness in the results.

Taking part would involve regular check-ups and medical tests before, during, and after your transplant. These would be similar to the tests you'd have as part of your standard transplant care, but there might be some additional blood tests or assessments specifically for the study. The doctors would monitor your new liver's function closely. The total duration of your participation would be explained fully by the study team, typically involving follow-up visits for a certain period after your transplant.

Potential risks and benefits

Taking part in any medical study carries potential benefits and risks. A potential benefit of this study is that the new medicine might help your new liver work better and improve your recovery after transplant. However, it's also possible that the medicine might not work for you, or it might cause side effects. Researchers will carefully monitor you for any potential problems. You will be given extensive information about known and possible side effects. Remember, joining this study is completely your decision, and you can withdraw at any time without affecting your standard medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What is an 'extended criteria donor' liver?

It's a liver used for transplant that might come from a donor who is older or has certain health factors, but is still suitable for transplant. Using these livers helps more people get transplants.

Will I definitely get the new medicine if I join?

Not necessarily. This is a "randomized" study, meaning you might receive the new medicine or the standard care, decided by chance, like flipping a coin. This helps doctors compare the treatments fairly.

What phase is this study?

This is a Phase I/II study. This means it's an early-stage study looking at the safety of the medicine and if it shows signs of working, before it's tested in much larger groups.

Will my regular doctors still look after me?

Yes, your transplant team and regular doctors will continue to provide all your medical care, whether you choose to join the study or not.

What if I change my mind about taking part?

You are free to leave the study at any time, for any reason, without it affecting the quality of your medical care.