Infection in an immunocompromised host Trials in Disease

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

This trial is designed to evaluate the safety and effectiveness of maribavir in treating cytomegalovirus infection in children and adolescents who have received either a hematopoietic stem cell transplant or a solid organ transplant. Cytomegalovirus is a common virus that can cause serious complications in patients with weakened immune systems, particularly those who have undergone transplant procedures.

Who can participate:

• Children under 18 years of age who have received a functioning solid organ transplant or hematopoietic stem cell transplant
• Patients who have a confirmed cytomegalovirus infection with specific levels of CMV DNA detected in their blood on two separate occasions
• Children who meet specific blood count requirements, including adequate levels of white blood cells (at least 500 absolute neutrophil count per mm3), platelets (at least 15,000 per mm3), and hemoglobin (at least 8 g/dL)
• Patients with adequate kidney function as measured by glomerular filtration rate
• Children who are able to swallow whole tablets until a liquid form becomes available
• Patients expected to live for at least 8 more weeks
• For girls who are old enough to have children, a negative pregnancy test is required, and all sexually active participants must agree to use birth control during the study and for 90 days afterward

Who cannot participate:

• Patients who have not received a hematopoietic stem cell transplant or a solid organ transplant
• Patients who do not have a confirmed cytomegalovirus infection
• Individuals who are 18 years or older

What the study involves:

The main focus of this trial is to evaluate how well maribavir works in clearing CMV infection from the body and to determine the most appropriate dosing for young patients. Participants will take maribavir tablets, which come in 200 mg doses, for up to eight weeks. The medication works by blocking a viral enzyme called UL97, which the virus needs to multiply.

Throughout the study, participants will have regular check-ups that include monitoring vital signs, conducting laboratory tests, and performing ECGs at specified visits. The researchers will measure how quickly the virus is cleared from the blood, with the goal of achieving complete clearance by Week 8. Some participants may receive a placebo to help compare the effects of the medication.

After the treatment period ends, there will be a 12-week follow-up phase to monitor for any return of the virus and to assess the long-term effectiveness of the treatment. The total monitoring period extends through Week 20.

Investigational drug: Maribavir is an antiviral medication that is taken orally. It is designed to stop the cytomegalovirus from multiplying in the body by targeting a specific enzyme the virus needs to replicate.