Actively Recruiting
Phase 3 Study of Maribavir Safety, Dosing, and Effectiveness for Treating Cytomegalovirus Infection in Children and Teens After Stem Cell or Organ Transplants
Led by Takeda · Updated on 2026-05-22
80
Participants Needed
53
Research Sites
N/A
Total Duration
On this page
Sponsors
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Takeda
Lead Sponsor
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Takeda Development Center Americas, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the safety, tolerability, and how the body processes maribavir in children and teenagers who have cytomegalovirus CMV infection after receiving a hematopoietic stem cell transplant HSCT or a solid organ transplant SOT. This phase 3 trial aims to find the best dose of maribavir using either a 200 mg tablet or a powder for oral suspension formulation. The study focuses on these young patients who have documented CMV infection and evaluates maribavirs antiviral activity along with its pharmacokinetics. Participants receive maribavir for up to 8 weeks with doses adjusted based on age and body weight. For ages 12 to less than 18 years, dosing ranges from 100 mg to 400 mg twice daily depending on weight. Those aged 6 to less than 12 years follow a similar dosing scheme, and children younger than 6 years may receive doses from 50 mg once or twice daily up to 400 mg twice daily. The medication is taken orally as tablets or powder for oral suspension during the treatment period. During the study, participants will have multiple blood tests to measure maribavir levels at various time points, and adverse events will be monitored up to 20 weeks. There is a 12-week follow-up period after treatment ends, during which participants will visit their doctor to assess continued viral control and safety. Researchers will also evaluate the clearance of CMV viremia, recurrence rates, and resistance development, along with participant feedback on medication palatability.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parent or legal representative must provide informed consent and participant assent as appropriate
- Male or female child or adolescent younger than 18 years at consent
- For children under 6 years, gestational age must be at least 39 weeks and weight at least 5 kg
- Recipient of a functioning hematopoietic stem cell transplant or solid organ transplant at screening
- Documented CMV infection with specific viral load thresholds confirmed by standardized lab tests
- Laboratory values within specified limits: neutrophil count ≥ 500/mm³, platelet count ≥ 15,000/mm³, hemoglobin ≥ 8 g/dL
- Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m²
- Female participants must be of nonchildbearing potential or have a negative pregnancy test if of childbearing potential
- Agree to comply with contraceptive requirements during treatment and 90 days after
- Life expectancy of at least 8 weeks
- Ability and willingness to comply with study procedures
- Confirmed negative HIV test within 3 months prior to dosing or during screening
You will not qualify if you...
- CMV tissue invasive disease involving central nervous system or retina
- Uncontrolled infections other than CMV at enrollment
- History of significant alcohol or drug abuse interfering with compliance
- Receiving or expected to require certain anti-CMV medications during treatment period
- Known allergy to maribavir or its components
- Severe gastrointestinal illness or absorption problems prior to dosing
- Need for mechanical ventilation or vasopressors at baseline
- Pregnant or nursing individuals
- Prior participation or withdrawal from this study
- Use of investigational agents or devices within 30 days before treatment
- Previous treatment with maribavir or CMV vaccine
- Any medical or surgical condition interfering with study or safety
- Severe liver disease or abnormal liver function tests
- Positive HIV test
- Active malignancy except nonmelanoma skin cancer or relapse of underlying malignancy
- Treatment for acute or chronic hepatitis B or C
- Need for strong CYP3A inducers
- Low body weight causing excessive blood volume withdrawal during study visits
Research Team
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Takeda Contact
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