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Efficacy and Safety Study of Maribavir Compared to Valganciclovir for the Treatment of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant Recipients

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 : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Shire

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

Condition or disease Intervention/treatment Phase
Cytomegalovirus (CMV) Drug: Maribavir Drug: Valganciclovir Drug: 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 : August 13, 2021
Estimated Study Completion Date : August 13, 2021

Resource links provided by the National Library of Medicine


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.

Drug: 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.

Drug: 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.

  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, 16 and 20 Regardless of Whether Study Assigned Treatment was Completed [ 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.

  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: Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1 ]
    Cmin of Maribavir will be assessed.

  9. Area Under the Concentration-Time Curve Over the 12-Hour Dosing Interval at Steady State AUC(0-tau) of Maribavir [ Time Frame: Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1 ]
    AUC(0-tau) of Maribavir will be assessed.

  10. Maximum Observed Plasma Concentration (Cmax) of Maribavir [ Time Frame: Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1 ]
    Cmax of Maribavir will be assessed.

  11. Time When Maximum Concentration is Observed (Tmax) of Maribavir [ Time Frame: Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1 ]
    Tmax of Maribavir will be assessed.

  12. Apparent Oral Clearance (CL/F) of Maribavir [ Time Frame: Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1 ]
    CL/F of Maribavir will be assessed.

  13. Apparent Volume of Distribution (Vz/F) of Maribavir [ Time Frame: Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1 ]
    Vz/F of Maribavir will be assessed.



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.
  • 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 x 10^9/L].
    2. Platelet count >= 25,000/mm^3 [25 x 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 cidofovir) 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 x ULN at screening (except for documented Gilbert's syndrome), as analyzed by local or central lab.
  • 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 866-842-5335 ClinicalTransparency@shire.com

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Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Site Contact    205-934-5191    jbaddley@uab.edu   
Principal Investigator: John Baddley, MD, MSPH         
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 Recruiting
Denver, Colorado, United States, 80218
Contact: Site Contact    720-754-4800    richard.nash@healthonecares.com   
Principal Investigator: Richard Nash, MD         
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 Recruiting
Chicago, Illinois, United States, 60637
Contact: Site Contact    773-702-1665      
Principal Investigator: Kathleen Mullane, DO, PharmD         
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    jyared@umm.edu   
Principal Investigator: Jean Yared, MD         
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21205
Contact: Site Contact    410-614-6702      
Principal Investigator: Robin Avery, MD         
United States, Massachusetts
Brigham and Women's Hospital/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         
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    313-916-5401      
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 Recruiting
Rochester, Minnesota, United States, 59905
Contact: Site Contact    507-284-3747    razonable.raymund@mayo.edu   
Principal Investigator: Raymund Razonable, MD         
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         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Site Contact    212-639-8361    papanicg@mskcc.org   
Principal Investigator: Genovefa Papanicolaou, MD         
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Site Contact    212-342-0530    rr336@cumc.columbia.edu   
Principal Investigator: Ran Reshef, MD, MSc         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Site Contact    215-662-7066    blumbere@mail.med.upenn.edu   
Principal Investigator: Emily Blumberg, MD         
United States, Tennessee
TriStar Centennial Medical Center Recruiting
Nashville, Tennessee, United States, 37203
Contact: Site Contact    210-575-6904    carlos.bachier@hcahealthcare.com   
Principal Investigator: Carlos Bachier, MD         
United States, Texas
St.David's South Austin Medical Center Recruiting
Austin, Texas, United States, 78704
Contact: Site Contact    201-575-6904    aravind.ramakrishnan@HCAhealthcare.com   
Principal Investigator: Aravind Ramakrishnan, MD         
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Site Contact    713-792-5381    rfchemaly@mdanderson.org   
Principal Investigator: Roy Chemaly, MD         
Texas Transplant Institute Recruiting
San Antonio, Texas, United States, 78229
Contact: Site Contact    210-575-8500    paul.shaughnessy@mhshealth.com   
Principal Investigator: Paul Shaughnessy, MD         
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 Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Site Contact    +61298457073    emily.blyth@sydney.edu.au   
Principal Investigator: Emily Blyth, 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 Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Contact: Site Contact    (902) 473-4642    stephen.couban@nshealth.ca   
Principal Investigator: Stephen Couban, MD         
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         
France
Hopital de Hautepierre Recruiting
Strasbourg Cedex, Bas-Rhin, France, 67098
Contact: Site Contact    +33388116728    bruno.lioure@chru-strasbourg.fr   
Principal Investigator: Bruno Lioure, MD         
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, 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         
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 Universitaire du Cancer de Toulouse - Oncopole Recruiting
Toulouse cedex 9, France, 31059
Contact: Site Contact    +33531156354    huynh.anne@iuct-oncopole.fr   
Principal Investigator: Anne Huynh, MD         
Germany
Universitaetsklinikum Muenster Recruiting
Muenster, Nordrhein-Westfalen, Germany, 48149
Contact: Site Contact    +4902518352801    stelljes@uni-muenster.de   
Principal Investigator: Matthias Stelljes, MD         
Universitatsklinikum Leipzig Recruiting
Leipzig, Sachsen, Germany, 04103
Contact: Site Contact    +493419713132    dietger.niederwieser@medizin.uni-leipzig.de   
Principal Investigator: Dietger Niederwieser, MD         
Zentralklinikum 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         
Robert Bosch Krankenhaus Recruiting
Stuttgart, Germany, 70376
Contact: Site Contact    +4971181015431    martin.kaufmann@rbk.de   
Principal Investigator: Martin Kaufmann, MD         
Universitatsklinikum Tubingen 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    +3614558218    premenyi@dpckorhaz.hu   
Principal Investigator: Peter Remenyi, 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 Recruiting
Zelarino, Venezia, Italy, 30174
Contact: Site Contact    +390419657357    michele.vespignani@aulss3.veneto.it   
Principal Investigator: Michele Vespignani, MD         
Azienda Ospedaliera Universitaria Careggi Recruiting
Firenze, Italy, 50134
Contact: Site Contact    +390557947672    riccardo.saccardi@aouc.unifi.it   
Principal Investigator: Riccardo Saccardi, 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         
Korea, Republic of
Dong-A University Hospital Recruiting
Busan, Korea, Republic of, 49201
Contact: Site Contact    +82512402608    kshmoon@dau.ac.kr   
Principal Investigator: Sung Hyun Kim, MD         
Keimyung University Dongsan Hospital Recruiting
Dae-gu, Korea, Republic of, 41931
Contact: Site Contact    +82532507719    dyr1160@dsmc.or.kr   
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
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, 80-952
Contact: Site Contact    +48583493070    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 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         
C.H. Regional Reina Sofia 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 Clinico Universitario de Valencia Recruiting
Valencia, Spain, 46010
Contact: Site Contact    +34963862625    carlos.solano@uv.es   
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, 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 Recruiting
Ankara, Turkey, 06590
Contact: Site Contact    +903125957375    gurman@medicine.ankara.edu.tr   
Principal Investigator: Gunhan Gurman         
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         
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         
Christie Hospital 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
Investigators
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Study Director: Study Director Shire

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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT02927067     History of Changes
Other Study ID Numbers: SHP620-302
2015-004726-34 ( EudraCT Number )
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Shire provides access to the de-identified individual participant data for eligible studies to aid qualified researchers in addressing legitimate scientific objectives. These IPDs will be provided 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 in the Data Sharing section of the www.shiretrials.com website. 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://www.shiretrials.com/en/our-commitment-to-transparency/data-sharing-with-researchers

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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