Catalent CTS LLC

To evaluate the safety and tolerability of maribavir in Chinese subjects. To evaluate the efficacy of maribavir treatment in the clearance of CMV viremia at the end of study week 8 in transplant recipients who are refractory or resistant to previous anti-CMV therapy; To evaluate the clearance of CMV viremia and symptom control achieved at the end of study week 8, and whether this effect is maintained until study week 12 (week 4 after the end of the treatment period), study week 16 (week 8 after the end of the treatment period/follow-up period), and study week 20 (week 12 after the end of the treatment period); To evaluate the efficacy of maribavir in the clearance of CMV viremia and symptom control achieved after completing 8 weeks of study treatment, and whether this effect is maintained until study week 12 (week 4 after the end of the treatment period), study week 16 (week 8 after the end of the treatment period/follow-up period), and study week 20 (week 12 after the end of the treatment period); To evaluate the clearance of CMV viremia and symptom control achieved after completing 8 weeks of study treatment, and whether this effect is maintained until study week 12 (week 4 after the end of the treatment period), study week 16 (week 8 after the end of the treatment period/follow-up period), and study week 20 (week 12 after the end of the treatment period); To evaluate the recurrence rate of CMV viremia during the 1-week follow-up, at any time during the study, and during the period when the subjects were receiving treatment and stopping treatment; To evaluate the recurrence of anti-CMV treatment during the follow-up period for subjects who achieved viremia clearance at week 8 of the study; To evaluate the spectrum of CMV gene mutations that cause resistance to maribavir; To evaluate the survival of the subjects; To determine the pharmacokinetic (PK) characteristics of maribavir in Chinese subjects.

This study tested a new drug called etavopivat in healthy Chinese subjects

Primary Objectives: To characterize the pharmacokinetic (PK) profile of maribavir and determine dosing regimens for the treatment of CMV infection in pediatric HSCT and SOT patients aged 0 to <18 years To evaluate the safety and tolerability of maribavir in children and adolescents Secondary Objectives: To evaluate the antiviral activity of maribavir on clearance of CMV viremia at the end of Week 8, regardless of the duration of study treatment To evaluate the maintenance of clearance of CMV viremia and symptom control achieved from Weeks 8 to 12 (4 weeks post-treatment), Week 16 (8 weeks post-treatment), and Week 20 (12 weeks post-treatment) To evaluate the recurrence of CMV viremia during study treatment and after discontinuation of study treatment To evaluate the time to first confirmed clearance of viremia To evaluate the recurrence of CMV viremia requiring treatment during the 12-week follow-up period in subjects with confirmed clearance of viremia at Week 8 To evaluate plasma CMV deoxyribonucleic acid (DNA) Time course of change in viral load from baseline (Visit 2/Day 0/Week 0) To assess the CMV mutational signature conferring resistance to maribavir To assess the acceptability and palatability of maribavir Exploratory objectives: To assess graft outcomes