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RecruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Antiviral Activity of Maribavir for the Treatment of Cytomegalovirus (CMV) Infection in Children and Adolescents Who Have Received a Hematopoietic Stem Cell Transplant (HSCT) or a Solid Organ Transplant (SOT)

This study is testing a new medicine called maribavir for children and teenagers who have a cytomegalovirus (CMV) infection after having a stem cell or organ transplant. CMV is a common virus that can cause problems after transplants. The main goals are to see how safe maribavir is, how the body handles the medicine, and how effective it is in treating the infection. We also want to find the best dose of maribavir for these young patients, using either a tablet or a liquid form.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Takeda
Enrolment target
80
Start
13 Nov 2023
Estimated completion
18 Jan 2027

What is this study about?

When someone has a major operation like a stem cell or organ transplant, their immune system is often weaker. This can make them more likely to get infections, and one common one is called Cytomegalovirus, or CMV. CMV can sometimes cause serious problems after a transplant.

This study is looking at a new medicine called maribavir. It's hoped that maribavir can help treat CMV infections in children and teenagers who have had these types of transplants. The researchers want to find out if the medicine is safe to use in this group, how the body processes it, and how well it actually works to fight the CMV infection.

Finding new and effective treatments for CMV is really important because it can significantly improve the health and recovery of young people after their transplants. This study aims to gather important information to see if maribavir could be a good option for future treatment.

Key takeaways

  • This study is testing a new CMV medicine for children and teenagers after transplants.
  • It aims to find out if maribavir is safe, how well it works, and the best dose.
  • Participation involves taking maribavir for 8 weeks and then 12 weeks of follow-up.
  • The transplant you received must be working well, and you must have a confirmed CMV infection.
  • You will have regular doctor visits throughout the study.
  • Your decision to join or leave the study will not affect your usual medical care.

Who may be eligible?

This study is for children and teenagers under 18 years old who have received either a solid organ transplant (like a kidney or liver) or a stem cell transplant. Currently, the transplant you received must be working well.

To join, you must have a confirmed CMV infection. This means tests have shown a certain level of the CMV virus in your blood. The doctors will also check your blood to make sure your infection is at a level that meets the study's requirements.

There are also some health checks you need to pass, like having certain levels of blood cells (white blood cells, platelets, and red blood cells) and good kidney function. If you're under 6 years old, you'll also need to have been born at full-term and weigh at least 5 kilograms.

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. Are you under 18 years old?
  2. Have you had a stem cell or organ transplant that is currently working well?
  3. Do you have a confirmed CMV infection with specific levels of the virus in your blood?
  4. Do your recent blood tests show healthy levels of certain blood cells and good kidney function?
  5. If you are under 6 years old, were you born at full term and do you weigh at least 5kg (about 11 pounds)?
Answer every question to see your result.

What does participation involve?

If you join the study, you'll take the medicine maribavir every day for 8 weeks. This medicine will be given as a tablet or a liquid form, depending on what's best for you. During this time, you'll have regular visits to your doctor to check your health and how the medicine is working. After the 8 weeks of treatment, there will be a follow-up period of 12 weeks. During these 12 weeks, you'll still need to visit your doctor for check-ups to make sure you're doing well and that the CMV infection is staying under control. The doctors will monitor your health throughout the entire study.

Potential risks and benefits

The potential benefits of joining this study could include receiving a new medicine that might help treat your CMV infection more effectively. However, it's also possible that maribavir may have side effects, just like any medicine. These will be carefully monitored by the study team. You'll be given detailed information about any known risks before you decide to take part. Remember, joining a study is always your choice, and you are free to withdraw at any time, for any reason, without it affecting your medical care.

Locations (53)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Nemours Children's Health - Wilmington - PIN
    Verified postcode
    Wilmington, United States· Recruiting
  • Johns Hopkins All Children's Hospital - Main - PIN
    Verified postcode
    St. Petersburg, United States· Recruiting
  • Ann and Robert H Lurie Childrens Hospital of Chicago - PIN
    Verified postcode
    Chicago, United States· Recruiting
  • University of Nebraska Medical Center -985400 Nebraska Medical Center
    Verified postcode
    Omaha, United States· Recruiting
  • Cincinnati Children's Hospital Medical Center - PIN
    Verified postcode
    Cincinnati, United States· Recruiting
  • Cook Children's Health Care System
    Verified postcode
    Fort Worth, United States· Recruiting
  • University of Texas MD Anderson Cancer Center - 1515 Holcombe Blvd
    Verified postcode
    Houston, United States· Recruiting
  • Texas Children's Hospital - Wallace Tower - PIN
    Verified postcode
    Houston, United States· Recruiting
  • Minderoo Children's Comprehensive Cancer Centre
    Verified postcode
    Randwick, Australia· Recruiting
  • Queensland Children's Hospital
    Unverified
    Woollangabba, Australia· Recruiting
  • Royal Children's Hospital Melbourne - PIN
    Verified postcode
    Parkville, Australia· Recruiting
  • Perth Children's Hospital
    Verified postcode
    Nedlands, Australia· Recruiting

Common questions

What is CMV infection?

CMV is a common virus that can cause problems, especially in people with weakened immune systems, like those who have had an organ or stem cell transplant.

What is maribavir?

Maribavir is a new medicine being tested to see if it can treat CMV infection in children and teenagers after transplants.

How long will I take the medicine?

You will take the medicine maribavir for 8 weeks, followed by 12 weeks of follow-up visits with your doctor.

Will I have to take tablets or a liquid?

Maribavir could be given as a tablet or a powder that you mix into a liquid. The study will work out which is best for you.

Do I have to take part in this study?

No, taking part in any study is completely your choice. You can decide not to join, or leave at any time, and it won't affect your regular medical care.

How to find out more

Takeda Contact

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 "A Study to Evaluate the Safety and Tolerability, Pharmacokin…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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