Overview

A Study of Maribavir in Japanese People With Cytomegalovirus (CMV) Infection

Status:
Not yet recruiting
Trial end date:
2023-04-11
Target enrollment:
0
Participant gender:
All
Summary
The main aim of the study is to check if treatment with maribavir can protect Japanese people against Cytomegalovirus (CMV) infection, and to check side effect from the study treatment and how much maribavir participants can take without getting side effects from it. Japanese recipients of a hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT) will take Maribavir tablets two times a day for 8 weeks in this study. During the study, participants will visit their study clinic 18 times as a maximum.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Takeda
Treatments:
Maribavir
Criteria
Inclusion Criteria

1. Be Japanese with Japanese nationality, >=16 years of age at the time of consent.

2. Be a recipient of HSCT or SOT that is functioning at the time of Screening.

3. Have a documented CMV infection with a screening value of >455 IU/mL in plasma in 2
consecutive assessments, separated by at least 1 day, as determined by a central
specialty laboratory qPCR or comparable quantitative CMV DNA results. Both samples
should be taken within 14 days prior to first dose of study treatment with the second
sample obtained within 5 days prior to first dose of study treatment at Visit 2/Day 0.

4. Have the current CMV infection after HSCT or SOT, either primary or reactivation,
which, in the investigator's opinion, requires treatment and have any of the
following.

1. Asymptomatic participants: The subjects do not have CMV tissue-invasive disease
or CMV syndrome (SOT subjects only) at Baseline, as determined by the
investigator according to the criteria specified by Ljungman et al., 2017.

2. Refractory or resistant participants: The participant must have a current CMV
infection that is refractory to the most recently administered of the anti-CMV
treatment agent(s). Refractory is defined as documented failure to achieve >1
log10 (common logarithm to base 10) decrease in CMV DNA level in plasma after a
14 day or longer treatment period with IV ganciclovir/oral valganciclovir, or IV
foscarnet.

5. Have all of the following results as part of screening laboratory assessments (results
from either the central laboratory or a local laboratory can be used for
qualification):

1. Absolute neutrophil count >=1,000/mm^3 (1.0 × 10^9/L)

2. Platelet count >=25,000/mm^3 (25 × 10^9/L)

3. Hemoglobin >=8 g/dL

4. Estimated creatinine clearance >=30 mL/minute (estimated glomerular filtration
rate by Modification of Diet in Renal Disease)

6. Be able to swallow tablets.

7. Have life expectancy of >=8 weeks.

8. Weigh >=40 kg.

Exclusion Criteria

1. Have central nervous system (CNS) CMV tissue-invasive disease or CMV retinitis as
assessed by the investigator at the time of Screening and prior to administration at
Visit 2/Day 0.

2. Be receiving valganciclovir, ganciclovir, foscarnet, or letermovir when study
treatment is initiated, or anticipated to require 1 of these agents during the 8-week
treatment period.

NOTE: Participants receiving letermovir must discontinue 3 days prior to first dose of
study treatment. Ganciclovir, valganciclovir, and foscarnet must be discontinued prior
to the first dose of study treatment.

3. Have known hypersensitivity to the active substance or to an excipient of the study
treatments.

4. Have severe vomiting, diarrhea, or other severe GI illness within 24 hours prior to
the first dose of study treatment that would preclude administration of oral
medication.

5. Require mechanical ventilation or vasopressors for hemodynamic support at the time of
Baseline.

6. Pregnant or nursing female.

7. Have received any investigational agent (including CMV-specific T-cells) with known
anti-CMV activity within 30 days before initiation of the study treatment at any time.

8. Have previously received maribavir.

9. Have serum aspartate aminotransferase (AST) >5 times upper limit of normal (ULN) at
Screening, or serum alanine aminotransferase (ALT) >5 times ULN at Screening, or total
bilirubin >=3.0* ULN at Screening (except for documented Gilbert's syndrome), as
analyzed by local or central laboratory.

10. Have known (previously documented) positive results for HIV. Participants must have a
confirmed negative HIV test result within 3 months of study entry or, if unavailable,
be tested by a local laboratory during the screening period.

11. Have active malignancy with the exception of nonmelanoma skin cancer, as determined by
the investigator. Participants who experience relapse or progression of their
underlying malignancy (for which HSCT or SOT was performed), as determined by the
investigator, are not to be enrolled.

12. Be undergoing treatment for acute or chronic hepatitis C.