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Trial record 1 of 1 for:    NCT02927067
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A Study of Maribavir Compared to Valganciclovir to Treat Cytomegalovirus Infections in People Who Have Received Stem Cell Transplants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02927067
Recruitment Status : Recruiting
First Posted : October 6, 2016
Last Update Posted : July 13, 2021
Sponsor:
Collaborator:
Takeda Development Center Americas, Inc.
Information provided by (Responsible Party):
Takeda ( Shire )

Brief 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.


Condition or disease Intervention/treatment Phase
Cytomegalovirus (CMV) Drug: Maribavir Drug: Valganciclovir Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 14, 2017
Estimated Primary Completion Date : May 20, 2022
Estimated Study Completion Date : May 20, 2022


Arm Intervention/treatment
Experimental: Maribavir/ Placebo
Participants will receive 400 milligrams (mg) of maribavir (2*200 mg tablets) twice daily (BID) orally along with a placebo matched to valganciclovir for 8 weeks.
Drug: Maribavir
Participants will receive 400 mg of maribavir BID orally.

Other: Placebo
Participants will receive placebo tablets matched to either maribavir or valganciclovir.

Active Comparator: Valganciclovir/ Placebo
Participants will receive 900 mg of valganciclovir (2*450 mg tablets) BID orally along with a placebo matched to maribavir for 8 weeks. Valganciclovir dose may be adjusted to 450 mg BID or 450 mg QD during the study for renal function impairment or neutropenia.
Drug: Valganciclovir
Participants will receive valganciclovir tablets orally.

Other: Placebo
Participants will receive placebo tablets matched to either maribavir or valganciclovir.




Primary Outcome Measures :
  1. Proportion of Participants With Confirmed Clearance of Plasma CMV DNA (CMV Viremia Clearance) at the End of Study Week 8, Regardless of Whether Study Assigned Treatment was Completed [ Time Frame: Week 8 ]
    Confirmed CMV viremia clearance is defined as plasma CMV DNA concentrations less than lower limit of quantification (LLOQ; i.e. <137 International units per milliliter [IU/mL]), when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive post baseline samples separated by at least 5 days. The participant must have received exclusively study-assigned treatment.


Secondary Outcome Measures :
  1. Proportion of Participants Who Maintained Confirmed CMV Viremia Clearance Achieved at the End of Study Week 8 Through Study Week 16, Regardless of Whether Study Assigned Treatment was Completed [ Time Frame: Week 8 through Week 16 ]
    Confirmed CMV viremia clearance is defined as plasma CMV DNA concentrations <LLOQ (<137 IU/mL), when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive post baseline samples separated by at least 5 days. It will be measured from plasma CMV DNA by quantitative PCR assay. The participant must have received exclusively study-assigned treatment and must also have symptom control.

  2. Proportion of Participants Who Achieve Confirmed CMV Viremia Clearance After 8 Weeks of Receiving Study-assigned Treatment [ Time Frame: Week 8 ]
    Confirmed CMV viremia clearance is defined as plasma CMV DNA concentrations <LLOQ (<137 IU/mL), when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive post baseline samples separated by at least 5 days. It will be measured from plasma CMV DNA by quantitative PCR assay.

  3. Proportion of Participants Who Maintained Confirmed CMV Viremia Clearance After Completion of 8 Weeks of Receiving Study-Assigned Treatment Through Study Weeks 12, 16 and 20 [ Time Frame: Week 8 through Weeks 12, 16 and 20 ]
    Confirmed CMV viremia clearance is defined as plasma CMV DNA concentrations <LLOQ (<137 IU/mL), when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive post baseline samples separated by at least 5 days. It will be measured from plasma CMV DNA by quantitative PCR assay.

  4. Proportion of Participants Who Maintained Confirmed CMV Viremia Clearance After Completion of 8 Weeks of Receiving Study-Assigned Treatment Through Study Weeks 12 and 20 Regardless of Whether Study Assigned Treatment was Completed [ Time Frame: Week 8 through Weeks 12 and 20 ]
    Confirmed CMV viremia clearance is defined as plasma CMV DNA concentrations <LLOQ (<137 IU/mL), when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive post baseline samples separated by at least 5 days. It will be measured from plasma CMV DNA by quantitative PCR assay. The participant must have received exclusively study-assigned treatment and also must have symptom control.

  5. Proportion of Participants With Confirmed Recurrence of Viremia While on Study Treatment and Off Treatment [ Time Frame: Baseline up to Week 20 ]
    Recurrence of CMV viremia is defined as plasma CMV DNA concentration greater than or equal to (>=) LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive plasma samples at least 5 days apart, after being unquantifiable (<LLOQ) for at least 5 days in 2 consecutive samples during the first 8 weeks of the study, during the 12 weeks of the followup study phase, and at any time during the study.

  6. Incidence of Grade 3 or 4 Neutropenia [ Time Frame: Baseline up to Week 8 ]
    Grade 3 and grade 4 neutropenia are defined as absolute neutophil count (ANC) <1000 per cubic millimeter (/mm^3) and ANC <500/mm^3 respectively.

  7. Number of Participants With Treatment-Emergent Adverse Events [ Time Frame: Baseline up to Week 20 ]
    An adverse event (AE) is any untoward medical occurrence in a clinical investigation participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE that has a start date on or after the first dose of study treatment, or that has a start date before the date of first dose of study treatment but increases in severity after the first dose of study treatment, will be considered a treatment-emergent AE (TEAE).

  8. Predose Concentration (Cmin) of Maribavir [ Time Frame: Weeks 1, 4, and 8: pre-morning dose ]
  9. Area Under the Concentration-Time Curve Over the 12-Hour Dosing Interval at Steady State AUC(0-tau) of Maribavir for Adolescent Participants Only [ Time Frame: Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1 ]
  10. Maximum Observed Plasma Concentration (Cmax) of Maribavir for Adolescent Participants Only [ Time Frame: Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1 ]
  11. Time When Maximum Concentration is Observed (Tmax) of Maribavir for Adolescent Participants Only [ Time Frame: Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1 ]
  12. Apparent Oral Clearance (CL/F) of Maribavir for Adolescent Participants Only [ Time Frame: Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1 ]
  13. Apparent Volume of Distribution (Vz/F) of Maribavir for Adolescent Participants Only [ Time Frame: Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
  • Have the current CMV infection as the first episode of CMV viremia after HSCT, either primary or reactivation, which in the investigator's opinion requires treatment.
  • Per investigator's judgment, be eligible for treatment with valganciclovir.
  • 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 to >=1000 per cubic millimeter (/mm^3) [1.0*10^9/L].
    2. Platelet count >=25,000/mm^3 [25*10^9/L].
    3. Hemoglobin >=8 grams per deciliter (g/dL).
    4. Estimated creatinine clearance >=30 milliliters per minute (mL/min).
  • Have a negative serum beta human chorionic gonadotropin (beta-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.
  • Be able to swallow tablets.
  • Have life expectancy of >=8 weeks.
  • Weigh >=40 kilograms (kg).
  • Be willing and have an understanding and ability to fully comply with study procedures and restrictions defined in the protocol.

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.
  • Be female and pregnant or nursing.
  • Have previously completed, discontinued, or have been withdrawn from this study.
  • Have received any investigational agent with known anti-CMV activity within 30 days before initiation of study treatment or CMV vaccine at any time.
  • Have received any unapproved agent or device within 30 days before initiation of study treatment.
  • 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 participant.
  • Have previously received maribavir.
  • Have serum aspartate aminotransferase (AST) greater than (>) 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.
  • Have known (previously documented) positive results for human immunodeficiency virus (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.
  • 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 was performed), as determined by the investigator, are not to be enrolled.
  • Be undergoing treatment for acute or chronic hepatitis C

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02927067


Contacts
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Contact: Shire Contact +1 866 842 5335 ClinicalTransparency@takeda.com

Locations
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United States, Alabama
University of Alabama at Birmingham Completed
Birmingham, Alabama, United States, 35294-0006
United States, California
UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Site Contact    310-825-6264    dwinston@mednet.ucla.edu   
Principal Investigator: Drew Winston, MD         
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Site Contact    650-868-8073    wesbrown@stanford.edu   
Principal Investigator: Janice Brown, MD         
United States, Colorado
Colorado Blood Cancer Institute Completed
Denver, Colorado, United States, 80218
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06520
Contact: Site Contact    203-785-3561    maricar.malinis@yale.edu   
Principal Investigator: Maricar Malinis, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Site Contact    404-712-2051    gmlyon@emory.edu   
Principal Investigator: George Lyon, MD         
United States, Illinois
University of Chicago Completed
Chicago, Illinois, United States, 60637
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Site Contact    708-327-3157    Patrick.Hagen@lumc.edu   
Principal Investigator: Patrick Hagen, MD         
United States, Maryland
University of Maryland School of Medicine Recruiting
Baltimore, Maryland, United States, 21201
Contact: Site Contact    410-328-0386 ext 6    jyared@umm.edu   
Principal Investigator: Jean Yared, MD         
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21205
Contact: Site Contact    443-287-4694    ravery4@jhmi.edu   
Principal Investigator: Robin Avery, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02115
Contact: Site Contact    617-732-8881    fmarty@partners.org   
Principal Investigator: Francisco Marty, MD         
Brigham and Womens Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Site Contact    617-732-8881    fmarty@partners.org   
Principal Investigator: Francisco Marty, MD         
UMass Memorial Medical Center Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Site Contact    508-856-1978    laura.gibson@umassmed.edu   
Principal Investigator: Laura Gibson, MD         
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Site Contact    313-916-2573    galanga1@hfhs.org   
Principal Investigator: George Alangaden, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Site Contact    612-625-8642    vanbu004@umn.edu   
Principal Investigator: Jo-Anne Young, MD         
Mayo Clinic - PPDS Completed
Rochester, Minnesota, United States, 59905
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Site Contact    551-996-5234    scott.rowley@hackensackmeridian.org   
Principal Investigator: Scott Rowley, MD         
United States, New York
Joan and sandford I. Weill Medical College of Cornell University Clinic Recruiting
New York, New York, United States, 10021
Contact: Site Contact    212-746-2646    tbs2001@med.cornell.edu   
Principal Investigator: Tsiporah Shore, MD         
Columbia University Medical Center Completed
New York, New York, United States, 10032
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Site Contact    212-639-8361    papanicg@mskcc.org   
Principal Investigator: Genovefa Papanicolaou, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Site Contact    215-662-7066    blumbere@pennmedicine.upenn.edu   
Principal Investigator: Emily Blumberg, MD         
United States, Tennessee
TriStar Centennial Medical Center Completed
Nashville, Tennessee, United States, 37203
United States, Texas
Saint Davids South Austin Medical Center Completed
Austin, Texas, United States, 78704
University of Texas MD Anderson Cancer Center Completed
Houston, Texas, United States, 77030
Texas Transplant Institute Completed
San Antonio, Texas, United States, 78229
United States, Washington
VA Puget Sound Health Care System - NAVREF Recruiting
Seattle, Washington, United States, 98108
Contact: Site Contact    206-764-2969    tchaunce@u.washington.edu   
Principal Investigator: Thomas Chauncey, MD         
United States, Wisconsin
The Medical College of Wisconsin, Inc. Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Site Contact    414-805-4600    phari@mcw.edu   
Principal Investigator: Parameswaran Hari, MD         
Australia, New South Wales
Westmead Hospital Completed
Westmead, New South Wales, Australia, 2145
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Site Contact    +61870740000    deepak.singhal@sa.gov.au   
Principal Investigator: Deepak Singhal, MBBS         
Australia, Victoria
Royal Melbourne Hospital Recruiting
Parkville, Victoria, Australia, 3050
Contact: Site Contact    +61393429407    joe.sasadeusz@mh.org.au   
Principal Investigator: Joe Sasadeusz, MD, PhD         
Belgium
UZ Antwerpen Recruiting
Wilrijk, Antwerpen, Belgium, 2650
Contact: Site Contact    +3238213250    alain.gadisseur@uza.be   
Principal Investigator: Alain Gadisseur, MD, PhD         
Institute Jules Bordet Recruiting
Bruxelles, Brussels, Belgium, 1000
Contact: Site Contact    +3225413706    mickael.aoun@bordet.be   
Principal Investigator: Mickaël Aoun, MD         
Cliniques Universitaires Saint-Luc Recruiting
Bruxelles, Brussels, Belgium, 1200
Contact: Site Contact    +3227641809    xavier.poire@uclouvain.be   
Principal Investigator: Xavier Poiré, MD         
University Hospital Gent Recruiting
Gent, Oost-Vlaanderen, Belgium, 9000
Contact: Site Contact    +3293326654    tessa.kerre@ugent.be   
Principal Investigator: Tessa Kerre, MD         
UZ Leuven Recruiting
Leuven, Vlaams Brabant, Belgium, 3000
Contact: Site Contact    +3216346880    johan.maertens@uzleuven.be   
Principal Investigator: Johan Maertens, MD         
AZ Sint-Jan AV Recruiting
Brugge, West-Vlaanderen, Belgium, 8000
Contact: Site Contact    +3250453061    dominik.selleslag@azsintjan.be   
Principal Investigator: Dominik Selleslag, MD         
CHU de Liège Recruiting
Liège, Belgium, 4000
Contact: Site Contact    +3243667201    e.willems@chu.ulg.ac.be   
Principal Investigator: Evelyne Willems, MD         
Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Site Contact    (604) 875-4588    alissa.wright@ubc.ca   
Principal Investigator: Alissa Wright, MD         
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Center Completed
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Hamilton Health Sciences Corporation Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Site Contact    (905) 521-2100 ext 42199    haider@mcmaster.ca   
Principal Investigator: Shariq Haider, MD         
Croatia
University Hospital Center Zagreb Recruiting
Zagreb, Croatia, 10000
Contact: Site Contact    +38598230220    rvrhovac@mef.hr   
Principal Investigator: Radovan Vrhovac, MD         
Czechia
Fakultni nemocnice v Motole Recruiting
Prague, Praha, Hlavní Mesto, Czechia, 150 00
Contact: Site Contact    +420224436433    petr.sedlacek@lfmotol.cuni.cz   
Principal Investigator: Petr Sedlacek, MD         
Ustav hematologie a krevni transfuze Recruiting
Praha, Czechia, 128 20
Contact: Site Contact    (420) 221-9772 ext 96    marketa.markova@uhkt.cz   
Principal Investigator: Marketa Stastna Markova, MD, MD         
France
Hopital de Hautepierre Completed
Strasbourg Cedex, Bas-Rhin, France, 67098
CHU de Bordeaux Recruiting
Pessac, Gironde, France, 33604
Contact: Site Contact    +33557656511    laurence.clement@chu-bordeaux.fr   
Principal Investigator: Laurence Clement, MD         
CHU de GRENOBLE Recruiting
GRENOBLE Cedex 9, Isère, France, 38043
Contact: Site Contact    +3347676757563409    athiebautbertrand@chu-grenoble.fr   
Principal Investigator: Anne Thiebaut-Bertrand, MD         
Hôtel Dieu Recruiting
Nantes, Loire-Atlantique, France, 44093
Contact: Site Contact    +33240083994    patrice.chevallier@chu-nantes.fr   
Principal Investigator: Patrice Chevallier, MD         
CHU Angers Recruiting
Angers Cedex 9, Maine-et-Loire, France, 49933
Contact: Site Contact    +332413544724475    syfrancois@chu-angers.fr   
Principal Investigator: Sylvie Francois, MD,MD         
Hopital Henri Mondor Recruiting
Créteil, Val-de-Marne, France, 94010
Contact: Site Contact    +33149812057    catherine.cordonnier@hmn.aphp.fr   
Principal Investigator: Catherine Cordonnier, MD         
Hopital Jean Minjoz Recruiting
Besnçon, France, 25030
Contact: Site Contact    +33381668232    edeconinck@chu-besancon.fr   
Principal Investigator: Eric Deconinck, MD, PhD         
Hôpital Universitaire Dupuytren Recruiting
Limoges, France, 87042
Contact: Site Contact    +33555058039    pascal.turlure@chu-limoges.fr   
Principal Investigator: Pascal Turlure, MD         
Institut Paoli Calmettes Completed
Nice, France, 7120
Hôpital Saint Louis Recruiting
Paris, France, 75475
Contact: Site Contact    +33142499639    david.michonneau@aphp.fr   
Principal Investigator: David Michonneau, MD         
EDOG - Institut Claudius Regaud - PPDS Recruiting
Toulouse cedex 9, France, 31059
Contact: Site Contact    +33531156354    huynh.anne@iuct-oncopole.fr   
Principal Investigator: Anne Huynh, MD         
Germany
Universitätsklinikum Münster Completed
Muenster, Nordrhein-Westfalen, Germany, 48149
Universität des Saarlandes Recruiting
Homburg, Saarland, Germany, 66421
Contact: Site Contact    +4968411615000    niels.murawski@uks.eu   
Principal Investigator: Niels Murawski, MD         
Universitatsklinikum Leipzig Recruiting
Leipzig, Sachsen, Germany, 04103
Contact: Site Contact    +493419713020    georg-nikolaus.franke@medizin.uni-leipzig.de   
Principal Investigator: Georg-Nikolaus Franke, MD         
Universitätsklinikum Augsburg Recruiting
Augsburg, Germany, 86156
Contact: Site contact    +498214002353    christoph.schmid@klinikum-augsburg.de   
Principal Investigator: Christoph Schmid, MD         
Helios Klinikum Berlin-Buch Recruiting
Berlin, Germany, 13150
Contact: Site Contact    +4930940152151    herrad.baurmann@helios-gesundheit.de   
Principal Investigator: Herrad Baurmann, MD         
Martin Luther Universitat Halle Wittenberg Recruiting
Halle, Germany, 6120
Contact: Site Contact    +493455577250    lutz.mueller@uk-halle.de   
Principal Investigator: Lutz Müller, MD         
Universitätsklinikum Hamburg Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Site Contact    +4940741055250    m.christopeit@uke.de   
Principal Investigator: Maximilian Christopeit, MD         
Universitätsklinik Rostock Recruiting
Rostock, Germany
Contact: Site Contact    +493814947421    christian.junghanss@med.uni-rostock.de   
Principal Investigator: Christian Junghanß, MD         
Robert Bosch Krankenhaus Recruiting
Stuttgart, Germany, 70376
Contact: Site Contact    +4971181015431    martin.kaufmann@rbk.de   
Principal Investigator: Martin Kaufmann, MD         
Universitätsklinikum Tübingen Recruiting
Tübingen, Germany, 72076
Contact: Site Contact    +4970712982711    wolfgang.bethge@med.uni-tuebingen.de   
Principal Investigator: Wolfgang Bethge, MD         
Hungary
Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet Recruiting
Budapest, Hungary, 1097
Contact: Site Contact    +3614558100 ext 8603    gopcsa.laszlo@dpckorhaz.hu   
Principal Investigator: Laszlo Gopcsa, MD         
Italy
Ospedale Infantile Regina Margherita Recruiting
Torino, Piemonte, Italy, 10126
Contact: Site Contact    +390113135230    franca.fagioli@unito.it   
Principal Investigator: Franca Fagioli, MD         
Azienda Ospedaliera Universitaria Integrata Di Verona Recruiting
Verona, Veneto, Italy, 37134
Contact: Site Contact    +390458124443    cristina.tecchio@univr.it   
Principal Investigator: Cristina Tecchio, MD         
Ospedale Dell'Angelo Completed
Zelarino, Venezia, Italy, 30174
Azienda Ospedaliera Universitaria Careggi Recruiting
Firenze, Italy, 50134
Contact: Site Contact    +393471226642    cutini.ilaria@hotmail.com   
Principal Investigator: Ilaria Cutini, MD         
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Recruiting
Milano, Italy, 20122
Contact: Site Contact    +3902550333353742    fonida@gmail.com   
Principal Investigator: Francesco Onida, MD         
Fondazione Policlinico Universitario A Gemelli Recruiting
Roma, Italy, 00168
Contact: Site Contact    +393355267999    patrizia.chiusolo@unicatt.it   
Principal Investigator: Patrizia Chiusolo, MD         
Azienda Ospedaliera Città della Salute e della Scienza di Torino Recruiting
Torino, Italy, 10126
Contact: Site Contact    (888) 888-8888    abusca.clinicaltrials@gmail.com   
Principal Investigator: Alessandro Busca, MD         
Korea, Republic of
Dong-A University Hospital Recruiting
Busan, Korea, Republic of, 49201
Principal Investigator: Sung Hyun Kim, MD         
Keimyung University Dongsan Hospital Recruiting
Daegu, Korea, Republic of, 41931
Principal Investigator: Young Rok Do, MD         
New Zealand
Auckland City Hospital Recruiting
Grafton, Auckland, New Zealand, 1023
Contact: Site Contact    +6493737599    p.browett@auckland.ac.nz   
Principal Investigator: Peter Browett, MBBS         
Canterbury Health Laboratories Recruiting
Christchurch, South Island, New Zealand, 8011
Contact: Site Contact    +6433640392    andrew.butler@cdhb.health.nz   
Principal Investigator: Andrew Butler, MB, MD         
Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu Recruiting
Wroclaw, Dolnoslaskie, Poland, 50-367
Contact: Site Contact    +48717842576    wrobel.t@onet.pl, twrobel@usk.wroc.pl   
Principal Investigator: Tomasz Wrobel, MD, PhD         
MTZ Clinical Research Sp z o o Recruiting
Warszawa, Mazowieckie, Poland, 02-106
Contact: Site Contact    +48225725959    wieslaw.jedrzejczak@wum.edu.pl   
Principal Investigator: Wieslaw Jedrzejczak, MD, PhD         
Uniwersyteckie Centrum Kliniczne - PPDS Recruiting
Gdansk, Poland, 80-214
Contact: Site Contact    +48583493079    mbienia@gumed.edu.pl   
Principal Investigator: Maria Bieniaszewska, MD, PhD         
Singapore
National University Hospital Recruiting
Singapore, Singapore, 119228
Contact: Site Contact    +656321470    liang_piu_koh@nuhs.edu.sg   
Principal Investigator: Liang Piu Koh, MBBS         
Singapore General Hospital (SGH) Recruiting
Singapore, Singapore, 169608
Contact: Site Contact    +6563214722    aloysius.ho.y.l@sgh.com.sg   
Principal Investigator: Aloysius Ho, MD         
Spain
Hospital Universitario Germans Trias i Pujol Recruiting
Badalona, Barcelona, Spain, 08916
Contact: Site Contact    +34934978987    cferra@iconcologia.net   
Principal Investigator: Christelle Ferra Coll, PhD         
Hospital Universitario Marques de Valdecilla Recruiting
Santander, Cantabria, Spain, 39008
Contact: Site Contact    +34942202520    maranzazu.bermudez@scsalud.es   
Principal Investigator: María Aranzazu Bermúdez Rodríguez, MD         
Complejo Asistencial Universitario de Salamanca - H. Clinico Recruiting
Salamanca, Castilla Y León, Spain, 37007
Contact: Site Contact    +34923291316    lvazlo@usal.es   
Principal Investigator: Maria Lourdes Vazquez Lopez, PhD         
Hospital Universitario Vall d'Hebrón - PPDS Recruiting
Barcelona, Spain, 08035
Contact: Site contact    +34932746414    pbarba@vhio.net   
Principal Investigator: Pere Barba Suñol, MD         
ICO l'Hospitalet - Hospital Duran i Reynals Recruiting
Barcelona, Spain, 08908-
Contact: Site Contact    +34932607750    rparody@iconcologia.net   
Principal Investigator: Rocio Parody, MD         
C.H. Regional Reina Sofia - PPDS Recruiting
Cordoba, Spain, 14004
Contact: Site Contact    +34957012972    rrojashurs@hotmail.com   
Principal Investigator: Rafael Rojas Contreras, PhD         
Hospital Universitario Virgen de Las Nieves Recruiting
Granada, Spain, 18014
Contact: Site Contact    +34958020379    manuel.jurado.sspa@juntadeandalucia.es   
Principal Investigator: Manuel Jurado Chacón, PhD         
Hospital Universitario de La Princesa Recruiting
Madrid, Spain, 28006
Contact: Site Contact    +34915202316    jrcamara@telefonica.net   
Principal Investigator: Rafael De la Camara, MD         
Hospital Universitario Ramon y Cajal Recruiting
Madrid, Spain, 28034
Contact: Site Contact    +34913368362    jlopezj.hrc@salud.madrid.org   
Principal Investigator: Javier Lopez Jimenez, PhD         
Hospital Universitario Puerta de Hierro - Majadahonda Recruiting
Madrid, Spain, 28222
Contact: Site Contact    +34911917809    rduarte.work@gmail.com   
Principal Investigator: Rafael Duarte Palomino, PhD         
Hospital Regional Universitario de Malaga - Hospital General Recruiting
Málaga, Spain, 29010
Contact: Site Contact    +34942202520    ai.gallardomorillo@gmail.com   
Principal Investigator: Ana Gallardo Morillo, MD         
Hospital Universitario de Donostia Recruiting
San Sebastian Gipuzkoa, Spain, 20014
Contact: Site Contact    +34943007041    OSID.ZERBITZUHEMATOLOGIA-TPH@osakidetza.eus   
Principal Investigator: Juan Carlos Vallejo Llamas, MD,PhD         
Hospital Clinico Universitario de Valencia Recruiting
Valencia, Spain, 46010
Contact: Site Contact    +34963862625    csolano.work@gmail.com   
Principal Investigator: Carlos Solano, PhD         
Hospital Universitari i Politecnic La Fe de Valencia Recruiting
Valencia, Spain, 46026
Contact: Site Contact    +34961245876    sanz_jai@gva.es   
Principal Investigator: Jaime Sanz Caballer, MD, PhD         
Switzerland
Universitätsspital Zürich Recruiting
Zurich, Switzerland, 8091
Contact: Site Contact    +41442553712    nicolas.mueller@usz.ch   
Principal Investigator: Nicolas Mueller, MD         
Turkey
Baskent University Medical Faculty Adana Practice and Research Center Recruiting
Adana, Turkey, 1250
Contact: Site Contact    +00905322366797    hakanozdogu@hotmail.com   
Principal Investigator: Hakan Ozdogu, MD         
Ankara University Medica Faculty Hematology Department Clinical Research Area PPDS Recruiting
Ankara, Turkey, 06590
Contact: Site Contact    +903125957375    gurman@medicine.ankara.edu.tr   
Principal Investigator: Gunhan Gurman, MD         
United Kingdom
Birmingham Heartlands Hospital Recruiting
West Midlands, Birmingham, United Kingdom, B9 5SS
Contact: Site Contact    +441214243699    bhuvan.kishore@heartofengland.nhs.uk   
Principal Investigator: Bhuvan Kishore, MD         
Hammersmith Hospital Recruiting
London, London, City Of, United Kingdom, W12 0HS
Contact: Site Contact    +442083835101    dragana.milojkovic@nhs.net   
Principal Investigator: Dragana Milojkovic, MD         
University College London Recruiting
London, London, City Of, United Kingdom, WC1E 6BT
Contact: Site Contact    +442076796236    karl.peggs@ucl.ac.uk   
Principal Investigator: Karl Peggs, MD         
St George's Hospital Recruiting
Tooting, London, United Kingdom, SW17 0QT
Contact: Site Contact    +442087253545    mickey.koh@stgeorges.nhs.uk   
Principal Investigator: Mickey Koh, MB         
Royal Liverpool University Hospital Recruiting
Liverpool, Merseyside, United Kingdom, L7 8XP
Contact: Site Contact    +441517064639    rahuman.salim@rlbuht.nhs.uk   
Principal Investigator: Rahuman Salim, MB, MRCPCH         
The Christie NHS Foundation Trust - PPDS Recruiting
Manchester, United Kingdom, M20 4BX
Contact: Site Contact    +441614463869    adrian.bloor@christie.nhs.uk   
Principal Investigator: Adrian Bloor, BA, MB, PhD         
Southampton University Hospitals NHS Trust Recruiting
Southampton, United Kingdom, SO16 6YD
Contact: Site Contact    +442381204163    k.h.orchard@southampton.ac.uk; kho@soton.ac.uk   
Principal Investigator: Kim Orchard, BSc, MB, PhD         
Sponsors and Collaborators
Shire
Takeda Development Center Americas, Inc.
Investigators
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Study Director: Study Director Shire
Additional Information:
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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT02927067    
Other Study ID Numbers: SHP620-302
2015-004726-34 ( EudraCT Number )
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: July 13, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
URL: https://vivli.org/ourmember/takeda/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Valganciclovir
Maribavir
Antiviral Agents
Anti-Infective Agents