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

NCT ID: NCT05137717

Last Updated: 2024-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-18
• Study Completion Date: 2023-06-27

Brief Summary

The main aim of the study is to check if maribavir can treat Japanese people with 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.

Conditions

Cytomegalovirus (CMV)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Maribavir

Maribavir 400 milligrams (mg), tablets, orally twice a day (BID) for up to 8 weeks.

Group Type: EXPERIMENTAL

Maribavir

Intervention Type: DRUG

Maribavir tablets

Interventions

Maribavir

Maribavir tablets

Intervention Type: DRUG

Other Intervention Names

SHP620; TAK-620

Eligibility 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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Ehime University Hospital

Tōon, Ehime, Japan

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Sapporo City General Hospital

Sapporo, Hokkaido, Japan

Sapporo Hokuyu Hospital

Sapporo, Hokkaido, Japan

University of Tsukuba Hospital

Tsukuba, Ibaraki, Japan

Imamura General Hospital

Kagoshima, Kagoshima-ken, Japan

Osaka International Cancer Institute

Osaka, Osaka, Japan

Osaka University Hospital

Suita, Osaka, Japan

Jichi Medical University Hospital

Shimotsuke, Tochigi, Japan

The Jikei University Hospital

Minato-ku, Tokyo, Japan

Toranomon Hospital

Minato-ku, Tokyo, Japan

Keio University Hospital

Shinjuku-ku, Tokyo, Japan

Yochomachi Clinic

Shinjuku-ku, Tokyo, Japan

Chiba University Hospital

Chiba, , Japan

Fukushima Medical University Hospital

Fukushima, , Japan

Kyoto University Hospital

Kyoto, , Japan

Okayama University Hospital

Okayama, , Japan

Osaka Metropolitan University Hospital

Osaka, , Japan

Jichi Medical University Saitama Medical Center

Saitama, , Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://clinicaltrials.takeda.com/study-detail/61a671acf571d4002a64b438

To obtain more information on the study, click here/on this link

Other Identifiers

jRCT2021210056

Identifier Type: REGISTRY

Identifier Source: secondary_id

TAK-620-3001

Identifier Type: -

Identifier Source: org_study_id