Study for the Treatment of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant Recipients

Description

The purpose of this study is to compare the efficacy and safety of maribavir to valganciclovir for the treatment of cytomegalovirus (CMV) infection in asymptomatic hematopoietic stem cell transplant recipients.

Study Start Date

April, 06 2017

Estimated Completion Date

August 2019

Interventions

  • Drug: Valganciclovir
  • Drug: Placebo
  • Drug: Maribavir

Study ID

Shire -- SHP620-302

Status

Recruiting

Trial ID

NCT02927067

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

550

Sponsor

Shire

Inclusion Criteria

    1. 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 subject before completing any study-related procedures. 2. Be greater than or equal to (>=) 16 years of age at the time of consent. 3. Be a recipient of hematopoietic stem cell transplant. 4. Have a documented asymptomatic CMV infection, with a screening value of CMV DNA >=2730 IU/mL to less than or equal to (<=) 273000 IU/mL in whole blood or >=910 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. 5. Have the current CMV infection as the first episode of CMV viremia after HSCT, either primary or reactivation. 6. Per investigator's judgment, be eligible for treatment with valganciclovir. 7. 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 >=1000/mm^3 [1.0 x 10^9/ liter (L)] 2. Platelet count >=25,000/mm^3 [25 x 10^9/L] 3. Hemoglobin >=8 gram per deciliter (g/dL). 4. Estimated creatinine clearance >=60mL/min/1.73 square meter (m^2) 8. Have a negative serum beta human chorionic gonadotropin (?-HCG) pregnancy test at screening, if a female of child bearing potential. Urine pregnancy tests may be done per institutional requirements however they are not sufficient for eligibility determination. Sexually active females of child bearing potential must agree to comply with any applicable contraceptive requirements of the protocol. If male, must agree to use an acceptable method of birth control, as defined in the protocol, during the study treatment administration period and for 90 days afterward the last dose of study treatment. 9. Be able to swallow tablets. 10. Have life expectancy of >=8 weeks. 11. Weigh >=40 kg. 12. Be willing and have an understanding and ability to fully comply with study procedures and restrictions defined in the protocol.

Exclusion Criteria

    1. Have CMV tissue invasive disease as assessed by the investigator at the time of screening and randomization at Visit 2/Day 0. 2. Have a CMV infection that is known to be genotypically resistant to ganciclovir, valganciclovir, foscarnet, or cidofovir based on documented evidence. 3. Be presenting with recurrent CMV infection (defined as a new detection of CMV infection in a subject who had at least one previously documented episode of CMV infection posttransplant, 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 subject 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. 4. Require ganciclovir, valganciclovir, foscarnet, or cidofovir administration for conditions other than CMV when study treatment is initiated (example: herpes simplex virus [HSV] coinfection requiring use of any of these agents after the randomization) or would need a co-administration with maribavir for CMV infection. 5. Be receiving leflunomide, or artesunate when study treatment is initiated. Note: Subjects 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. Subjects receiving artesunate must discontinue the use prior to the first dose of study treatment. 6. Be on treatment with anti-CMV agents (ganciclovir, valganciclovir, foscarnet or cidofovir) for the current CMV infection for longer than 72 hours. Note: A subject who is receiving these anti-CMV agents must discontinue their use before the first dose of study treatment. A subjects who may be receiving cidofovir must discontinue this antiviral at least 14 days prior to randomization at Visit 2/Day 0 and the first dose of study treatment. Note: Subjects who were administered these anti-CMV agents for prophylaxis, should have these treatments completed at least 2 weeks prior to the study entry or start of the treatment for current infection, whichever comes first and have undetectable CMV DNA (based on local laboratory) for at least two weeks between the completion of this treatment and onset of the current infection. 7. Have known hypersensitivity to the active substance or to an excipient of the study treatments. 8. 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. 9. Require mechanical ventilation or vasopressors for hemodynamic support at the time of randomization. 10. Be female and pregnant or nursing. 11. Have previously completed, discontinued, or have been withdrawn from this study. 12. Have received any investigational agent with known anti-CMV activity within 30 days before initiation of study treatment or CMV vaccine at any time. 13. Have received any unapproved agent or device within 30 days before initiation of study treatment. 14. Have any clinically significant medical or surgical condition that, in the investigator's opinion, could interfere with interpretation of study results, contraindicate the administration of the assigned study treatment, or compromise the safety or well-being of the subject. 15. Have previously received maribavir. 16. 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 x ULN at screening (except for documented Gilbert's syndrome), as analyzed by local or central lab. 17. Have known (previously documented) positive results for human immunodeficiency virus (HIV). 18. Have active malignancy with the exception of nonmelanoma skin cancer, as determined by the investigator. Subjects who experience relapse or progression of their underlying malignancy (for which HSCT was performed), as determined by the investigator, are not to be enrolled. 19. Be undergoing treatment for acute or chronic hepatitis C.

Gender

All

Ages

16 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (33)

Study Location Distance Name Phone Email
Brigham and Womens HospitalBeth Israel Deaconess Medical Center - Boston, Massachusetts 2.6 miles Francisco Marty MD 617-732-8881 fmarty@partners.org
Brigham and Womens HospitalBeth Israel Deaconess Medical Center - Boston, Massachusetts 2.6 miles Francisco Marty MD 617-732-8881 fmarty@partners.org
Brigham and Womens HospitalBeth Israel Deaconess Medical Center - Boston, Massachusetts 2.6 miles Francisco Marty MD 617-732-8881 fmarty@partners.org
Columbia University Medical Center - New York, New York 181.2 miles Ran Reshef MD MSc 212-342-0530 rr336@cumc.columbia.edu
Columbia University Medical Center - New York, New York 181.2 miles Ran Reshef MD MSc 212-342-0530 rr336@cumc.columbia.edu
Columbia University Medical Center - New York, New York 181.2 miles Ran Reshef MD MSc 212-342-0530 rr336@cumc.columbia.edu
Memorial Sloan Kettering Cancer Center - New York, New York 184.8 miles Genovefa Papnicolaou MD 212-639-8361 papanicg@mskcc.org
Memorial Sloan Kettering Cancer Center - New York, New York 184.8 miles Genovefa Papnicolaou MD 212-639-8361 papanicg@mskcc.org
Memorial Sloan Kettering Cancer Center - New York, New York 184.8 miles Genovefa Papnicolaou MD 212-639-8361 papanicg@mskcc.org
University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Emily Blumberg MD 215-662-7066 blumbere@mail.med.upenn.edu
University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Emily Blumberg MD 215-662-7066 blumbere@mail.med.upenn.edu
University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Emily Blumberg MD 215-662-7066 blumbere@mail.med.upenn.edu
Johns Hopkins Hospital - Baltimore, Maryland 356.4 miles Terry Woessner 410-614-6702 twoessn1@jhmi.edu
Johns Hopkins Hospital - Baltimore, Maryland 356.4 miles Terry Woessner 410-614-6702 twoessn1@jhmi.edu
Johns Hopkins Hospital - Baltimore, Maryland 356.4 miles Terry Woessner 410-614-6702 twoessn1@jhmi.edu
Henry Ford Health System - Detroit, Michigan 612.3 miles Katrina Williams 313-916-5401 kwilli35@hfhs.org
Henry Ford Health System - Detroit, Michigan 612.3 miles Katrina Williams 313-916-5401 kwilli35@hfhs.org
Henry Ford Health System - Detroit, Michigan 612.3 miles Katrina Williams 313-916-5401 kwilli35@hfhs.org
University of Chicago - Chicago, Illinois 848.0 miles Jennifer Theusch 773-702-1665 jtheusch@medicine.bsd.uchicago.edu
University of Chicago - Chicago, Illinois 848.0 miles Jennifer Theusch 773-702-1665 jtheusch@medicine.bsd.uchicago.edu
University of Chicago - Chicago, Illinois 848.0 miles Jennifer Theusch 773-702-1665 jtheusch@medicine.bsd.uchicago.edu
Emory University - Atlanta, Georgia 932.0 miles George Lyon MD 404-712-2051 gmlyon@emory.edu
Emory University - Atlanta, Georgia 932.0 miles George Lyon MD 404-712-2051 gmlyon@emory.edu
Emory University - Atlanta, Georgia 932.0 miles George Lyon MD 404-712-2051 gmlyon@emory.edu
University of Alabama at Birmingham - Birmingham, Alabama 1,052.1 miles John Baddley MD MSPH 205-934-5191 jbaddley@uab.edu
University of Alabama at Birmingham - Birmingham, Alabama 1,052.1 miles John Baddley MD MSPH 205-934-5191 jbaddley@uab.edu
University of Alabama at Birmingham - Birmingham, Alabama 1,052.1 miles John Baddley MD MSPH 205-934-5191 jbaddley@uab.edu
Mayo Clinic - Rochester, Minnesota 2,114.7 miles Raymund Razonable MD 507-284-3747 razonable.raymund@mayo.edu
Mayo Clinic - Rochester, Minnesota 2,114.7 miles Raymund Razonable MD 507-284-3747 razonable.raymund@mayo.edu
Mayo Clinic - Rochester, Minnesota 2,114.7 miles Raymund Razonable MD 507-284-3747 razonable.raymund@mayo.edu
UCLA Medical Center - Los Angeles, California 2,605.2 miles Drew Winston MD 310-825-6264 dwinston@mednet.ucla.edu
UCLA Medical Center - Los Angeles, California 2,605.2 miles Drew Winston MD 310-825-6264 dwinston@mednet.ucla.edu
UCLA Medical Center - Los Angeles, California 2,605.2 miles Drew Winston MD 310-825-6264 dwinston@mednet.ucla.edu

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