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RecruitingPHASE4INTERVENTIONAL

Evaluation of the Benefits of Administering Immunosuppressive Drugs as Single Daily Doses Over the First Year After Liver Transplantation (EASY)

This study is for people who have had a liver transplant. It’s looking at different ways to take anti-rejection medicines. Currently, some of these medicines are taken twice a day. This study wants to find out if taking certain anti-rejection medicines all in one single daily dose works just as well and is safe. The main goal is to see if a single daily dose helps people remember to take their medicines better and improves their daily life after transplant, without affecting their health outcomes. We'll be comparing different types of anti-rejection medications and how often they're taken to find the best approach for patients.

At a glance

Status
Recruiting
Phase
PHASE4
Sponsor
University Hospital, Limoges
Enrolment target
162
Start
15 Apr 2025
Estimated completion
15 Apr 2028

What is this study about?

When you have a liver transplant, you need to take special medicines called “anti-rejection drugs” or “immunosuppressants” for the rest of your life. These medicines stop your body from seeing the new liver as foreign and trying to reject it. It's really important to take them exactly as prescribed. However, remembering to take medicines every day, sometimes twice a day, can be difficult and can affect your daily life.

This study is trying to make taking these important medicines simpler. We want to see if taking some of these anti-rejection medicines just once a day works as well and is as safe as taking them twice a day. The hope is that taking pills less often will make it easier for people to remember, reduce stress, and improve their overall quality of life after a liver transplant, without increasing the risk of your body rejecting the new organ.

We will be looking at different versions of two main anti-rejection medicines, tacrolimus and mycophenolate mofetil. Some participants will take tacrolimus once a day and mycophenolate mofetil twice a day, while others will try taking both medicines just once a day. We'll compare how well these different approaches work, how easy they are for patients, and how they affect your health and wellbeing in the first year after your transplant.

Key takeaways

  • This study is about making anti-rejection medicine easier to take for liver transplant patients.
  • It aims to see if taking medicines once a day is as good as twice a day.
  • The study focuses on improving quality of life and how well patients take their medicines.
  • You would participate for the first year after your liver transplant.
  • You will have regular check-ups and some home blood tests.

Who may be eligible?

This study is looking for adults who have recently had their very first liver transplant from a deceased donor. You would need to have had your transplant less than four weeks before joining the study.

There are also some reasons why you might not be able to join. For example, if you received only part of a liver, or if you had any other organ transplanted at the same time as your liver. You also can't join if you have certain other serious health problems, are taking specific medicines that might interfere with the study drugs, or are pregnant or breastfeeding.

Finally, to join, you must be able to understand what the study involves and agree to take part by signing a consent form. You also need to be willing to follow the study plan and attend all visits.

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.

  1. I had my first liver transplant less than four weeks ago from a deceased donor.
  2. I am aged 18 or older.
  3. I haven't had any other organs transplanted, only my liver.
  4. I don't have certain serious health problems (your doctor can check this).
  5. I am not pregnant or breastfeeding, and I am using effective contraception if needed.
Answer every question to see your result.

What does participation involve?

If you join this study, you will be assigned to one of four groups, each taking a slightly different combination and timing of your anti-rejection medicines (tacrolimus and mycophenolate mofetil). Some groups will take both medicines once a day, and others will take one once a day and the other twice a day. All participants will take their medicines for the first year after their transplant.

You will have regular check-ups at the hospital, which will involve blood tests to monitor your medicine levels and overall health. Some of these blood tests might involve using a special device at home, which allows you to take small blood samples yourself, meaning fewer trips to the hospital. You will also be asked to answer questions about your quality of life and how easy you find it to take your medicines. The study will last for the first year after your liver transplant.

Potential risks and benefits

Participating in this study might offer the benefit of a simpler medicine schedule, potentially making it easier to manage your daily life after a transplant. However, as with any medical study, there are potential risks, such as side effects from the medicines, or the possibility that a once-daily regimen might not be as effective for everyone. All study medications are already approved and widely used. You can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (18)

  • CHU de Besançon - Hôpital Jean Minjoz
    Verified postcode
    Besançon, France· Recruiting
  • Beaujon hospital - APHP
    Verified postcode
    Clichy, France· Recruiting
  • CHU de Dijon Bourgogne
    Verified postcode
    Dijon, France· Recruiting
  • CHu de Grenoble
    Verified postcode
    Grenoble, France· Not yet recruiting
  • Lille university hospital
    Verified postcode
    Lille, France· Recruiting
  • Limoges university hospital
    Verified postcode
    Limoges, France· Recruiting
  • Lyon university hospital
    Verified postcode
    Lyon, France· Recruiting
  • APHP
    Verified postcode
    Marseille, France· Recruiting
  • Montpellier university hospital
    Verified postcode
    Montpellier, France· Recruiting
  • Nice university hospital
    Verified postcode
    Nice, France· Recruiting
  • Pitie Salpetriere hospital - APHP
    Verified postcode
    Paris, France· Recruiting
  • Bordeaux university hospital
    Verified postcode
    Pessac, France· Recruiting

Common questions

What are anti-rejection medicines?

These are vital medicines you take after a transplant to stop your body from rejecting the new organ.

What is the main goal of this study?

To see if taking anti-rejection medicines once a day is as safe and effective as twice a day, and if it improves patients' lives.

How long will the study last for me?

You will participate in the study for the first year after your liver transplant.

Will I have to pay to be in the study?

No, you will not have to pay to take part in this study.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time without giving a reason, and your medical care will not be affected.

How to find out more

Caroline MONCHAUD, Pharm D

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Evaluation of the Benefits of Administering Immunosuppressiv…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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