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A Study of Maribavir Compared to Valganciclovir to Treat Cytomegalovirus Infections in People Who Have Received Stem Cell Transplants | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study of Maribavir Compared to Valganciclovir to Treat Cytomegalovirus Infections in People Who Have Received Stem Cell Transplants

A Phase 3, Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Compared to Valganciclovir for the Treatment of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant Recipients

NCT02927067•Shire

View on ClinicalTrials.gov

Summary

This study is about treatment options for cytomegalovirus infections in people who have received stem cell transplants. The main aim of the study is to check if the cytomegalovirus infection can no longer be detected after treatment with marivabir or valganciclovir. Participants will take 2 tablets of marivabir or valganciclovir and 2 tablets of placebo twice a day for 8 weeks. A placebo will look like marivabir or valganciclovir but will not have any medicine in it. After treatment, each participant will be followed up for up to 12 weeks. Participants will visit their study clinic up to 18 times during the study.

Eligibility

Age

16 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Be able to provide written, personally signed, and dated informed consent to participate in the study before completing any study-related procedures. As applicable, a parent/both parents or legally authorized representative (LAR) must provide signature of informed consent and there must be documentation of assent by the participants before completing any study-related procedures. During the COVID-19 public health emergency, informed consent from a potential or current trial participant may, if permitted by local laws and regulations, be obtained via electronic informed consent (eIC) capabilities or an electronic face-to-face consent interview when these individuals are unable to travel to the site (FDA COVID-19 Guidance, 27 January 2021, Q11).
•Be greater than or equal to (\>=) 16 years of age at the time of consent.
•Be a recipient of hematopoietic stem cell transplant.
•Have a documented asymptomatic CMV infection, with a screening value of CMV DNA \>=1365 International Units per millilitre (IU/mL) to less than or equal to (\<=) 273000 IU/mL in whole blood or \>=455 IU/mL to \<=91000 IU/mL in plasma in 2 consecutive assessments, separated by at least 1 day, as determined by local or central specialty laboratory quantitative polymerase chain reaction (qPCR) or comparable quantitative CMV DNA results. Both samples should be taken within 14 days prior to randomization with second sample obtained within 5 days prior to randomization. Same laboratory and same sample type (whole blood or plasma) should be used for these assessments. Asymptomatic CMV infection is defined as an infection that does not present with tissue invasive CMV disease, as assessed by the investigator. Participants with CMV DNA less than (\<) 910 and \>=455 IU/mL in plasma or \<2730 and \>=1365 IU/mL in whole blood will also need to meet at least 1 of the following criteria for high-risk CMV infection to be eligible:
•1. Human leukocyte antigen (HLA)-related (sibling) donor with at least 1 mismatch at 1 of the following 3 HLA-gene loci: HLA-A, -B or -DR,
•2. Haploidentical donor
•3. Unrelated donor with at least 1 mismatch at 1 of the following 4 HLA -gene loci: HLA-A, -B, -C and -DRB1,
•4. Use of umbilical cord blood as stem cell source,
•5. Use of ex vivo T-cell-depleted grafts,
•6. Grade 2 or greater graft-versus-host-disease (GVHD), requiring the use of systemic corticosteroids (defined as the use of \>=1 milligram per kilogram per day (mg/kg/day) of prednisone or equivalent dose of another corticosteroid).
+12 more criteria

Exclusion Criteria

•Have CMV tissue invasive disease as assessed by the investigator at the time of screening and randomization at Visit 2/Day 0.
•Have a CMV infection that is known to be genotypically resistant to ganciclovir, valganciclovir, foscarnet, or cidofovir based on documented evidence.
•Be presenting with recurrent CMV infection (defined as a new detection of CMV infection in a participants who had at least one previously documented episode of CMV infection post-transplant, and who has had at least 2 weeks of undetectable CMV DNA between the episodes during active surveillance, based on same local laboratory and same sample type). The Participants must also have been off any anti-CMV treatment between the current and prior infection. Otherwise, the current infection may be considered continuation of the prior infection.
•Require ganciclovir, valganciclovir, foscarnet, or cidofovir administration for conditions other than CMV when study treatment is initiated (example: herpes simplex virus \[HSV\] co-infection requiring use of any of these agents after the randomization) or would need a co-administration with maribavir for CMV infection.
•Be receiving leflunomide, letermovir, or artesunate when study treatment is initiated.
•Note: Participants who may be receiving leflunomide must discontinue the use at least 14 days prior to randomization at Visit 2/Day 0 and the first dose of study treatment. Participants receiving letermovir must discontinue use 3 days prior to first dose of study treatment. Participants receiving artesunate must discontinue the use prior to the first dose of study treatment.
•Be on treatment with anti-CMV agents (ganciclovir, valganciclovir, foscarnet or letermovir) for the current CMV infection for longer than 72 hours.
•Have known hypersensitivity to the active substance or to an excipient of the study treatments.
•Have severe vomiting, diarrhea, or other severe gastrointestinal illness within 24 hours prior to the first dose of study treatment that would preclude administration of oral medication.
•Require mechanical ventilation or vasopressors for hemodynamic support at the time of randomization.
+10 more criteria

Locations (129)

University of Alabama at Birmingham

Birmingham, Alabama, United States

UCLA Medical Center

Los Angeles, California, United States

Stanford University

Stanford, California, United States

Colorado Blood Cancer Institute - PPDS

Denver, Colorado, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Emory University

Atlanta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

University of Maryland School of Medicine

Baltimore, Maryland, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Key Dates

Start Date

April 14, 2017

Primary Completion Date

July 1, 2022

Completion Date

July 1, 2022

Last Updated

March 3, 2023

Enrollment

553

ACTUAL participants

Conditions

Cytomegalovirus (CMV)

Interventions

Maribavir

DRUG

Valganciclovir

DRUG

Placebo

OTHER

A Study of Maribavir in Chinese Adults With Cytomegalovirus (CMV) Infections

NCT06439342

Cytomegalovirus (CMV)

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Maribavir Compared to Valganciclovir to Treat Cytomegalovirus Infections in People Who Have Received Stem Cell Transplants

Inclusion Criteria

Exclusion Criteria

A Study of Maribavir in Chinese Adults With Cytomegalovirus (CMV) Infections

Comparison Diagnostic Tests for the Diagnosis of CYTOmegalovirus Organ Disease in Patients With intestinalBOweL Diseases

A Study of Maribavir in Adults With Post-transplant Cytomegalovirus (CMV) Infection

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