AuthorisedTherapeutic confirmatory (Phase III)Interventional

ANAKINRA IN THE TREATMENT OF PEDIATRIC ACUTE MYOCARDITIS. ANAPEM

This study, called ANAPEM, is testing a new medicine called Kineret for children who have a heart problem called acute myocarditis. Myocarditis means the heart muscle becomes inflamed, which can make it hard for the heart to pump blood around the body properly. The study wants to see if Kineret can help these children's hearts recover quicker. Researchers will compare children who receive Kineret to those who receive a salty water injection (which acts as a dummy treatment). They will closely monitor the children's heart function, especially how well their left ventricle (a main pumping chamber) is working, over a few days, weeks, and months. This is a Phase III study, meaning it's a later stage of testing to confirm if the treatment is effective and safe.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

110

Start

04 Sep 2025

PEDIATRIC ACUTE MYOCARDITIS

What is this study about?

This study is called ANAPEM, and it's designed to help children who have a condition called acute myocarditis. Acute myocarditis happens when the heart muscle suddenly becomes inflamed. This inflammation can make it harder for the heart to pump blood effectively, which is a serious problem. The main aim of this study is to find out if a medicine called Kineret can help children with this condition recover faster and better than current treatments.

Researchers want to see if Kineret helps the main pumping chamber of the heart (called the left ventricle) get back to pumping blood strongly. They will measure this by looking at something called the 'ejection fraction,' which tells them how much blood the heart pumps out with each beat. They'll check this at different times, starting just three days after treatment begins. They'll also be looking at other important things like how many children need a special breathing machine (called ECMO), if any children need a heart transplant, and how many experience side effects.

This is a 'Phase III' study, which means it's one of the final stages of testing before a new medicine might be approved for wider use. It's about confirming if Kineret is both safe and effective for treating acute myocarditis in children. The study will involve giving some children Kineret and others a 'dummy' treatment (salty water) to fairly compare the results. This helps ensure that any positive effects seen are truly due to the Kineret.

Key takeaways

The study is investigating a new treatment (Kineret) for children with acute myocarditis.
It aims to see if Kineret helps the heart recover faster and pump better.
Children will receive either Kineret or a dummy treatment, selected at random.
Heart function will be closely monitored with scans and blood tests.
Participation involves regular hospital visits and follow-up for up to six months.
This is a Phase III study, a crucial step in testing new medicines.

Who may be eligible?

This study is looking for children of all ages and genders who have been diagnosed with acute myocarditis.

More specific details about who can and cannot join the study will be discussed by your doctor. This might include certain health conditions, other medications the child is taking, or previous treatments. It’s important to share all relevant health information with the study team to make sure it's safe for your child to participate.

If you think your child might be eligible, the first step is to talk to their doctor or the study team. They can check all the specific requirements and help you understand if this study could be an option for your child.

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.

Is your child diagnosed with acute myocarditis?
Are they currently receiving hospital care for this condition?
Are they of any age (from babies to teenagers)?
Have you discussed all your child's current medications and health conditions with their doctor?

Answer every question to see your result.

What does participation involve?

If your child joins this study, they will receive either the study medicine, Kineret, or a dummy treatment (salty water) by injection. This will happen while they are in hospital. The study team will regularly check your child's heart function using scans like echocardiograms (a heart ultrasound), especially in the first few days and weeks. They will also take blood samples to measure heart markers and check for any side effects. Your child will have several follow-up assessments over a period of up to six months to track their recovery and overall health. The exact number of visits and tests will be explained in detail by the study team, but it will involve close monitoring throughout the study period.

Potential risks and benefits

Taking part in a study like this could potentially help your child's heart recover, and it also contributes to new knowledge that might help other children in the future. However, there are also potential risks; Kineret might cause side effects, such as allergies, changes in blood cells, or impacts on liver tests, and the dummy treatment won't have any direct benefit for the heart. The study team will monitor your child very closely for any issues. You are free to withdraw your child from the study at any time, for any reason, without it affecting their ongoing medical care.

Locations (1)

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

—
Unverified
France

Common questions

What is acute myocarditis?

It's a serious condition where the heart muscle suddenly becomes inflamed, making it harder for the heart to pump blood effectively.

What is Kineret?

Kineret is a medicine being tested in this study to see if it can help reduce the inflammation in children's hearts.

Will my child definitely get the new medicine?

No, children will be randomly assigned to receive either Kineret or a 'dummy' treatment (salty water), so not everyone will get the active drug.

How will the doctors know if the treatment is working?

They will do heart scans (echocardiograms) to measure how well your child's heart is pumping blood, especially after 3 days, 7 days, and 28 days.

What is a 'Phase III' study?

It's a late stage of testing where researchers check if a new medicine is truly effective and safe for treating a condition, often comparing it to a standard treatment or a dummy treatment.