TAK-620-2004

Recruiting

A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Antiviral Activity of Maribavir for the Treatment of Children and Teenage Transplant Recipients With CMV Infection

Clinicaltrials.gov

#NCT05319353

|

EudraCT

#2021-004279-15

|

jRCT

#jRCT2031230753

The main aim of this study is to find out the safety, tolerability and pharmacokinetics (PK) of maribavir for the treatment of CMV infection in children and teenagers after HSCT or SOT and to identify the optimal dose of maribavir using a 200 milligrams (mg) adult tablet formulation or other formulation based on PK modeling. The participants will be treated with maribavir for 8 weeks. Participants need to visit their doctor during 12-week follow-up period.

FR

DE

ES

7+

Interventional Phase 3 clinical trial.

What medical conditions are being studied?

Cytomegalovirus (CMV)

What is the clinical trial testing?

Maribavir

How many participants are being enrolled?

80

Are placebos part of the clinical trial?

No

When is the clinical trial being conducted?

Nov 2023 - Nov 2026

How long is participation in the clinical trial?

Participants will be in the study for no longer than 22 weeks.

Sex

All

Age

Up to 17 years

Healthy volunteers?

No

Must be boys or girls less than (<) 18 years of age. For Cohort 3 only, must have a gestational age of at least 38 weeks and a minimum weight of 5 kilograms (kg).

Must be a recipient of a solid organ transplant (SOT) or an hematopoietic stem cell transplant (HSCT) that is functioning at the time of screening.

Must have a documented cytomegalovirus (CMV) infection.

Cannot have CMV tissue invasive disease involving the central nervous system (CNS) or retina.

Cannot have uncontrolled other type of infection.

Cannot have known hypersensitivity to Maribavir.

Additional entry criteria will be discussed with the study doctor.

Primary outcome measures

Maximum Observed Plasma Concentration (Cmax) of Maribavir [Time Frame: Pre-dose, 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)]

Time to Maximum Observed Concentration (Tmax) of Maribavir [Time Frame: Pre-dose, 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)]

Minimum Plasma Concentration (Cmin) of Maribavir [Time Frame: Pre-dose, 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1); Pre-dose on Day 28 (Week 4); Pre-dose and 2 to 4 hours post-dose on Day 56 (Week 8)]

Area Under the Plasma Concentration-Time Curve Over the 1 Dosing Interval of 12 Hours at Steady State (AUC0-tau) of Maribavir [Time Frame: Pre-dose, 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)]

Half-Life (t1/2) of Maribavir [Time Frame: Pre-dose, 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)]

Terminal Elimination Rate Constant (lambdaz) of Maribavir [Time Frame: Pre-dose, 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)]

Apparent Volume of Distribution (Vz/F) of Maribavir [Time Frame: Pre-dose, 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)]

Apparent Oral Clearance (CL/F) of Maribavir [Time Frame: Pre-dose, 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)]

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs [Time Frame: From start of study drug administration up to follow-up (Week 20)]

Secondary outcome measures

Percentage of Participants With Confirmed CMV viremia Clearance at Week 8 [Time Frame: At Week 8]

Percentage of Participants who Achieve Maintenance of Confirmed CMV Viremia Clearance and Symptom Control at Week 8 Through Weeks 12, 16 and 20 [Time Frame: At Week 8 through Weeks 12, 16, and 20]

Percentage of Participants With Confirmed Recurrence of CMV Viremia on Study Treatment and Off Study Treatment [Time Frame: Up to Week 20]

Time to First Confirmed Viremia Clearance [Time Frame: Up to Week 20]

Percentage of Participants With Confirmed Recurrence of CMV Viremia Treated With Alternative Anti-CMV Treatment During 12-Week Follow-up Period in Participants With Confirmed Viremia Clearance at Week 8 [Time Frame: From Week 8 through Week 20]

Change From Baseline in Log10 Plasma CMV Deoxyribonucleic Acid (DNA) Load [Time Frame: Baseline up to Week 20]

Number of Participants who Develop CMV Resistance to Maribavir [Time Frame: Up to Week 12]

Summary Scores for Palatability Assessment of Maribavir [Time Frame: At Weeks 1, 4, and 8]