Study on Maribavir for Treating Cytomegalovirus in Children and Adolescents Post-Transplant

3 1 1 1

What is this study about?

This clinical trial is focused on studying 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). The treatment being tested is a medication called maribavir, which is taken in the form of tablets. The purpose of the study is to evaluate the safety, dosage, and effectiveness of maribavir in treating CMV infection in this specific group of young patients.

Participants in the study will take maribavir for a period of up to eight weeks. During this time, researchers will monitor the participants to assess how their bodies process the medication and to identify the most suitable dosing regimens. The study will also look at how well the medication is tolerated by the participants and whether it effectively reduces the presence of CMV in their bodies. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of maribavir.

The study will involve regular check-ups and tests to ensure the safety of the participants and to gather information on how the medication is working. These assessments will include monitoring for any side effects, checking vital signs, and conducting laboratory tests. The goal is to determine if maribavir can be a safe and effective treatment option for children and adolescents with CMV infection following a transplant.

1 joining the study

Upon joining the study, the patient will begin by taking the medication maribavir, which is provided in the form of 200 mg film-coated tablets.

The medication is administered orally.

2 medication administration

The patient will take the maribavir tablets as prescribed by the study protocol. The specific dosage and frequency will be determined based on the patient’s individual needs and the study’s guidelines.

The treatment aims to manage cytomegalovirus (CMV) infection in children and adolescents who have received a hematopoietic stem cell transplant (HSCT) or a solid organ transplant (SOT).

3 monitoring and assessments

Throughout the study, the patient will undergo regular monitoring to assess the safety and effectiveness of the treatment.

This includes checking vital signs, conducting laboratory evaluations, and performing ECGs at specified visits.

4 evaluation of treatment response

The study will evaluate the patient’s response to the treatment by measuring the clearance of CMV DNA from the plasma.

The goal is to achieve confirmed clearance of CMV DNA at Week 8, with continued monitoring through Week 20.

5 follow-up period

After the treatment period, the patient will enter a follow-up phase to monitor for any recurrence of CMV viremia and to assess the long-term effectiveness of the treatment.

This follow-up will last for 12 weeks post-treatment.

Who Can Join the Study?

The child’s parent or legal guardian must sign a consent form, and the child must agree to participate if they are old enough to understand.
The child must be under 18 years old. For certain groups, they must be at least 38 weeks old from birth and weigh at least 5 kg.
The child must have received a solid organ transplant (SOT) or a hematopoietic stem cell transplant (HSCT) that is working properly at the time of joining the study.
The child must have a confirmed Cytomegalovirus (CMV) infection with specific levels of CMV DNA in their blood, checked twice with at least one day between tests.
The child must have certain blood test results:
- Absolute neutrophil count (a type of white blood cell) of at least 500 per mm³
- Platelet count (cells that help with blood clotting) of at least 15,000 per mm³
- Hemoglobin (a protein in red blood cells) of at least 8 g/dL
The child must have a certain level of kidney function, measured by a test called the glomerular filtration rate.
If the child is a girl who can have children, she must have a negative pregnancy test. All participants who are sexually active must agree to use birth control during the study and for 90 days after.
The child must be able to swallow a whole tablet until a liquid form of the medicine is available.
The child must be expected to live for at least 8 more weeks.
The child and their family must be willing and able to follow the study rules and procedures.

Who Cannot Join the Study?

Patients who have not received a hematopoietic stem cell transplant (HSCT) or a solid organ transplant (SOT). These are medical procedures where patients receive healthy cells or organs to replace damaged ones.
Patients who do not have a Cytomegalovirus (CMV) infection. This is a common virus that can cause problems in people with weakened immune systems.
Patients who are not children or adolescents. The study is only for those from 0 years to less than 18 years of age.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hopital Necker Enfants Malades	Paris	France
Medizinische Hochschule Hannover	Hanover	Germany
University Hospital Jena KöR	Jena	Germany
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
University Childrens Hospital Queen Fabiola	Brussels	Belgium
Covubhjhg Ubuhzkleuyqgtn Spuvpsseu	Woluwe-Saint-Lambert	Belgium
Uvjbwlfpys Micsuda Cdfysw Hsahsbdbksgtvvcez	Hamburg	Germany
Utzbfxkkedyivnriaumup Mffmiuxw Aky	Munster	Germany
Uptqgststulxjjagofqcw Wwtseglnl Acv	Wuerzburg	Germany
Fhubgmtxa Pvwv Lb Igvmiydihkrtg Bjuwcojlw Dwm Hwohugxb Uasojsftjymbv Lb Plc	Madrid	Spain
Hoiafpvg Vwgv dyinimpn	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	13.11.2023
France	Not recruiting	13.11.2023
Germany	Not recruiting	13.11.2023
Spain	Not recruiting	13.11.2023

Trial locations

Investigated drugs:

Maribavir

Maribavir is a medication being studied for its ability to treat cytomegalovirus (CMV) infections. This trial focuses on children and adolescents who have received a hematopoietic stem cell transplant or a solid organ transplant. The study aims to understand how the body processes maribavir and to find the best dosing regimens for young patients. Additionally, the trial evaluates the safety and tolerability of maribavir in these patients.

Cytomegalovirus (CMV) infection – This infection is caused by the cytomegalovirus, a common virus that can affect people of all ages. In children and adolescents who have received a hematopoietic stem cell transplant (HSCT) or a solid organ transplant (SOT), CMV infection can occur when the virus, which may have been dormant, becomes active again. The virus can spread through bodily fluids and may not always cause symptoms, but when it does, it can lead to fever, fatigue, and swollen glands. In transplant recipients, the infection can be more severe due to their weakened immune systems. The progression of the disease can vary, with some individuals experiencing mild symptoms while others may have more significant health issues. Monitoring and managing the infection is crucial to prevent complications in these vulnerable patients.

Trial ID:

2023-508988-73-00

Protocol code:

TAK-620-2004

NCT ID:

NCT05319353

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Maribavir for Treating Cytomegalovirus in Children and Adolescents Post-Transplant

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?