AzTrials
AzTrials

Cytomegalovirus (CMV)Phase 3NCT02927067

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

A Phase 3 study testing Maribavir and Valganciclovir in people with Cytomegalovirus (CMV), run by Shire at 129 sites in 23 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Cytomegalovirus (CMV)
What is being tested?
Maribavir and Valganciclovir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
553 participants
Where
129 sitesin 23 countries
Study dates
14 Apr 2017to 1 Jul 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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:
  • 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,
  • Haploidentical donor
Show all 22Show fewer
  • Unrelated donor with at least 1 mismatch at 1 of the following 4 HLA -gene loci: HLA-A, -B, -C and -DRB1,
  • Use of umbilical cord blood as stem cell source,
  • Use of ex vivo T-cell-depleted grafts,
  • 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):
  • Absolute neutrophil count to >=1000 per cubic millimeter (/mm^3) [1.0*10^9/L].
  • Platelet count >=25,000/mm^3 [25*10^9/L].
  • Hemoglobin >=8 grams per deciliter (g/dL).
  • 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.

Who cannot join

  • 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.
Show all 20Show fewer
  • 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

Trial locations and contacts

129 sites in 23 countries.

129 sites in 23 countries

United States28 sites

  • Emory University

    Atlanta, Georgia, 30322

  • Saint Davids South Austin Medical Center

    Austin, Texas, 78704

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21205

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02115

  • Brigham and Womens Hospital

    Boston, Massachusetts, 02115

  • University of Chicago

    Chicago, Illinois, 60637

  • Colorado Blood Cancer Institute - PPDS

    Denver, Colorado, 80218

  • Harper University Hospital

    Detroit, Michigan, 48201

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • UCLA Medical Center

    Los Angeles, California, 90095

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • The Medical College of Wisconsin, Inc.

    Milwaukee, Wisconsin, 53226

  • University of Minnesota

    Minneapolis, Minnesota, 55454

  • TriStar Centennial Medical Center

    Nashville, Tennessee, 37203-1624

  • Yale University School of Medicine

    New Haven, Connecticut, 06520

  • Joan and sandford I. Weill Medical College of Cornell University Clinic

    New York, New York, 10021

  • Columbia University Medical Center

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Mayo Clinic - PIN

    Rochester, Minnesota, 59905

  • Texas Transplant Institute

    San Antonio, Texas, 78229

  • VA Puget Sound Health Care System - NAVREF - PPDS

    Seattle, Washington, 98108

  • Stanford University

    Stanford, California, 94305

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

Spain14 sites

  • Hospital Universitario Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Universitario Vall d'Hebrón - PPDS

    Barcelona, 08035

  • ICO l'Hospitalet Hospital Duran i Reynals

    Barcelona, 08908-

  • C.H. Regional Reina Sofia - PPDS

    Córdoba, 14004

  • Hospital Universitario Virgen de Las Nieves

    Granada, 18014

  • Hospital Universitario de La Princesa

    Madrid, 28006

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Madrid, 28222

  • Hospital Regional Universitario de Malaga - Hospital General

    Málaga, 29010

  • Complejo Asistencial Universitario de Salamanca - H. Clinico

    Salamanca, Castille and León, 37007

  • Hospital Universitario de Donostia

    San Sebastian Gipuzkoa, 20014

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

Other trials in Spain

France13 sites

  • CHU Angers

    Angers, Maine-et-Loire, 49933

  • Hopital Jean Minjoz

    Besnçon, 25030

  • Hopital Henri Mondor

    Créteil, Val-de-Marne, 94010

  • CHU de GRENOBLE

    Grenoble, Isère, 38043

  • Hôpital Universitaire Dupuytren

    Limoges, Haute-Vienne, 87042

  • Hôtel Dieu

    Nantes, Loire-Atlantique, 44093

  • Institut Paoli Calmettes

    Nice, 7120

  • Hôpital Saint Antoine

    Paris, 75012

  • Hôpital Saint Louis

    Paris, 75475

  • CHU de Bordeaux

    Pessac, Gironde, 33604

  • Institut de Cancérologie Strasbourg Europe

    Strasbourg, Bas-Rhin, 67033

  • Hopital de Hautepierre

    Strasbourg, Bas-Rhin, 67098

  • EDOG - Institut Claudius Regaud - PPDS

    Toulouse, 31059

Other trials in France

Germany11 sites

  • Universitätsklinikum Augsburg

    Augsburg, 86156

  • Helios Klinikum Berlin-Buch

    Berlin, 13125

  • Martin Luther Universitat Halle Wittenberg

    Halle, 6120

  • Universitätsklinikum Hamburg Eppendorf

    Hamburg, 20251

  • Universität des Saarlandes

    Homburg, Saarland, 66424

  • Universitatsklinikum Leipzig

    Leipzig, Saxony, 04103

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, Rhineland-Palatinate, 55131

  • Universitätsklinikum Münster

    Münster, North Rhine-Westphalia, 48149

  • Universitätsklinik Rostock

    Rostock

  • Robert Bosch Krankenhaus

    Stuttgart, 70376

  • Universitätsklinikum Tübingen

    Tübingen, 72076

Other trials in Germany

Belgium8 sites

  • AZ Sint-Jan AV

    Bruges, West-Vlaanderen, 8000

  • Institute Jules Bordet

    Brussels, Brussels Capital, 1000

  • Cliniques Universitaires Saint-Luc

    Brussels, Brussels Capital, 1200

  • UZ Antwerpen

    Edegem, Antwerpen, 2650

  • University Hospital Gent

    Ghent, Oost-Vlaanderen, 9000

  • Universitair Ziekenhuis Brussel - PIN

    Jette, Brussels Capital, 1090

  • UZ Leuven

    Leuven, Vlaams Brabant, 3000

  • CHU de Liège

    Liège, 4000

Other trials in Belgium

China8 sites

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

  • Xiangya Hospital Central South University

    Changsha, 410008

  • Nanfang Hospital Southern Medical University

    Guangzhou, Guangdong, 510515

  • Guangzhou First People's Hospital

    Guangzhou, 510180

  • The First Affiliated Hospital, College of Medicine, Zhejiang University

    Hangzhou Zhejiang, 310003

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

  • Henan Cancer Hospital

    Zhengzhou, 450008

Other trials in China

Italy7 sites

  • Ospedale Dell'Angelo

    Brescia, Lombardy, 30174

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • Fondazione Policlinico Universitario A Gemelli

    Roma, 00168

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Torino, 10126

  • Ospedale Infantile Regina Margherita - INCIPIT - PIN

    Turin, Piedmont, 10126

  • Azienda Ospedaliera Universitaria Integrata Di Verona

    Verona, Veneto, 37134

Other trials in Italy

United Kingdom7 sites

  • Clatterbridge Cancer Centre Liverpool

    Liverpool, Merseyside, L7 8XP

  • Hammersmith Hospital

    London, London, City of, W12 0HS

  • University College London

    London, London, City of, WC1E 6BT

  • The Christie NHS Foundation Trust - PPDS

    Manchester, M20 4BX

  • Southampton University Hospitals NHS Trust

    Southampton, SO16 6YD

  • St George's Hospital

    Tooting, London, SW17 0QT

  • Birmingham Heartlands Hospital

    West Midlands, Birmingham, B9 5SS

Other trials in United Kingdom

Israel4 sites

  • Rambam Medical Center - PPDS

    Haifa, 31999

  • Hadassah Medical Center - PPDS

    Jerusalem, Jerusalem, 90000

  • Sheba Medical Center - PPDS

    Ramat Gan, Central District, 5262000

  • Tel Aviv Sourasky Medical Center PPDS

    Tel Aviv, 64239

Other trials in Israel

Australia3 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Canada3 sites

  • Queen Elizabeth II Health Sciences Center

    Halifax, Nova Scotia, B3H 2Y9

  • Hamilton Health Sciences Corporation

    Hamilton, Ontario, L8N 3Z5

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Poland3 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

  • MTZ Clinical Research Sp z o o - PRATIA - PPDS

    Warsaw, Masovian Voivodeship, 02-106

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu

    Wroclaw, Lower Silesian Voivodeship, 50-367

Other trials in Poland

Russia3 sites

  • Regional Oncology Center

    Irkutsk, 664035

  • Kirov Research Institute of Haematology and Blood Transfusion

    Kirov, 610027

  • First St. Petersburg State Medical University n.a. I.P Pavlov

    Saint Petersburg, Sankt-Peterburg, 197022

Other trials in Russia

Austria2 sites

  • Elisabethinen Hospital Linz

    Linz, 4020

  • Medizinische Universitat Wien (Medical University of Vienna)

    Vienna, State of Vienna

Other trials in Austria

Czechia2 sites

  • Fakultni nemocnice v Motole

    Prague, Praha, Hlavní Mesto, 150 00

  • Ustav hematologie a krevni transfuze

    Prague, 128 20

Other trials in Czechia

Greece2 sites

  • Attikon University General Hospital

    Athens, Attica, 124 64

  • Georgios Papanikolaou General Hospital of Thessaloniki

    Thessaloniki, 57010

Other trials in Greece

New Zealand2 sites

  • Canterbury Health Laboratories

    Christchurch, South Island, 8011

  • Auckland City Hospital

    Grafton, Auckland, 1023

Other trials in New Zealand

Singapore2 sites

  • National University Hospital

    Singapore, 119228

  • Singapore General Hospital (SGH)

    Singapore, 169608

Other trials in Singapore

South Korea2 sites

  • Dong-A University Hospital

    Busan, 49201

  • Keimyung University Dongsan Hospital

    Daegu, 41931

Other trials in South Korea

Turkey (Türkiye)2 sites

  • Baskent University Medical Faculty Adana Practice and Research Center

    Adana, 1250

  • Ankara University Medica Faculty Hematology Department Clinical Research Area PPDS

    Ankara, 06590

Other trials in Turkey (Türkiye)

Croatia1 site

  • University Hospital Center Zagreb

    Zagreb, 10000

Other trials in Croatia

Hungary1 site

  • Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet

    Budapest, 1097

Other trials in Hungary

Switzerland1 site

  • Universitätsspital Zürich

    Zurich, 8091

Other trials in Switzerland

About this study

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

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.

Being tested
Maribavir, Valganciclovir, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MaribavirDrug

    Participants will receive 400 mg of maribavir BID orally.

  • ValganciclovirDrug

    Participants will receive valganciclovir tablets orally.

  • PlaceboOther

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

Study groups in NCT02927067
Study groupRoleWhat they receive
Valganciclovir 900 mg BIDActive comparatorParticipants received 900 milligrams (mg) of valganciclovir along with a placebo matched to maribavir, twice daily (BID) orally for 8 weeks. Valganciclovir dose was allowed to be adjusted to 450 mg BID or 450 mg QD based on renal function impairment assessed at baseline or development of neutropenia during the study.
Receives: Drug: Valganciclovir; Other: Placebo
Maribavir 400 mg BIDExperimentalParticipants received 400 mg of maribavir along with a placebo matched to valganciclovir, BID orally for 8 weeks.
Receives: Drug: Maribavir; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Achieved Confirmed Clearance of Plasma Cytomegalovirus (CMV) Deoxyribose Nucleic Acid (DNA) at the End of Study 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. To be considered a responder for the primary endpoint, the participant must have received exclusively study-assigned treatment (regardless of whether study-assigned treatment was completed).

    Measured: Week 8

Secondary outcomes (16)

  1. Number of Participants Who Achieved Confirmed CMV Viremia Clearance and CMV Infection Symptom Control at the End of Week 8, Followed by Maintenance of Treatment Effect at Week 16

    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. To be considered a responder for this key secondary endpoint, the participant must have received exclusively study-assigned treatment (regardless of whether study-assigned treatment was completed). CMV Infection Symptom Control is defined as no new clinical findings of CMV tissue invasive disease. Maintenance of Treatment Effect is defined as maintaining confirmed CMV viremia clearance and CMV infection symptom control through Week 16.

    Measured: Week 8 up to Week 16

  2. Number of Participants Who Achieved Confirmed Clearance of Plasma CMV DNA (CMV Viremia Clearance) at Week 8 After Receiving 8 Weeks of Study Assigned Treatment

    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. To be considered a responder for this secondary endpoint, the participant must have received exclusively study-assigned treatment for 8 weeks. Participants who discontinued treatment early were non-responders for this endpoint.

    Measured: Week 8

  3. Number of Participants Who Achieved Confirmed CMV Viremia Clearance After Receiving 8 Weeks of Study-assigned Treatment Through Weeks 12, 16 and 20

    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. To be considered a responder for this secondary endpoint, the participant must have received exclusively study-assigned treatment for 8 weeks.

    Measured: Week 8 through Weeks 12, 16 and 20

  4. Number of Participants Who Maintained Confirmed CMV Viremia Clearance at Week 8 After Receiving Study-Assigned Treatment Through Study Weeks 12 and 20 Regardless of Whether Study Assigned Treatment Was Completed

    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. To be considered a responder for this secondary endpoint, the participant must have received exclusively study-assigned treatment (regardless of whether the 8-week study-assigned treatment was completed or discontinued early) and had no symptoms of tissue invasive CMV disease at Week 8, Week 8 through Week 12, and Week 8 through Week 20, respectively.

    Measured: Week 8 through Weeks 12 and 20

  5. Number of Participants With Confirmed Recurrence of Viremia During First 8 Weeks of the Study

    Recurrence of CMV viremia is defined as plasma CMV DNA concentration greater than or equal to (>=) 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 plasma samples at least 5 days apart, after being unquantifiable (<LLOQ, i.e. <137 IU/mL) for at least 5 days in 2 consecutive samples during the first 8 weeks of the study, during the 12 weeks of the follow up study phase, and at any time during the study.

    Measured: Up to Week 8

  6. Number of Participants With Confirmed Recurrence of Viremia During the Follow-up Period

    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 follow up study phase, and at any time during the study.

    Measured: From Week 9 up to Week 20

  7. Number of Participants With Confirmed Recurrence of Viremia at Any Time During the Study

    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 follow up study phase, and at any time during the study.

    Measured: Up to Week 20

  8. Number of Participants With Confirmed Recurrence of Viremia While on Study Treatment and Off Treatment

    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 follow up study phase, and at any time during the study.

    Measured: Baseline up to Week 20

  9. Number of Participants With Grade 3 or 4 (Shift From Baseline Grade <3) and Grade 4 Neutropenia (Shift From Baseline Grade <4) While on Study Treatment

    Grade 3 and grade 4 neutropenia are defined as absolute neutrophil count (ANC) <1000 per cubic millimeter (/mm^3) and ANC <500/mm^3 respectively. Incidence of Grade 3 or 4 neutropenia represents the percentage of participants with Grade <3 (or missing) neutropenia at baseline, but Grade 3 or 4 while on study treatment. Incidence of Grade 4 neutropenia represents the number of participants with Grade <4 (or missing) neutropenia at baseline, but Grade 4 while on study treatment.

    Measured: From start of study drug to end of study drug + 1 day (up to approximately Week 8)

  10. Number of Participants With Treatment-Emergent Adverse Events During the On-Treatment Period

    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).

    Measured: From the start of the study treatment to 7 days after the last dose of study treatment (up to approximately Week 9)

  11. Predose Concentration (Cmin) of Maribavir

    The primary plasma maribavir concentration dataset (primary concentration dataset) includes all plasma maribavir concentrations. Missing PK sampling times are imputed according to the sparse sampling schedule in primary concentration dataset.

    Measured: Weeks 1, 4, and 8: pre-morning dose

  12. Area Under the Concentration-Time Curve Over the 12-Hour Dosing Interval at Steady State AUC(0-tau) of Maribavir for Adolescent Participants Only

    Measured: Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1

  13. Maximum Observed Plasma Concentration (Cmax) of Maribavir for Adolescent Participants Only

    Measured: Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1

  14. Time When Maximum Concentration is Observed (Tmax) of Maribavir for Adolescent Participants Only

    Measured: Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1

  15. Apparent Oral Clearance (CL/F) of Maribavir for Adolescent Participants Only

    Measured: Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1

  16. Apparent Volume of Distribution (Vz/F) of Maribavir for Adolescent Participants Only

    Measured: Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2016 (estimated)
  2. Study start14 Apr 2017
  3. Primary completion1 Jul 2022
  4. Study completion1 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
553 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02927067
Sponsor's protocol ID
SHP620-302
Other IDs
2015-004726-34, 2015
Status last verified
Feb 2023
First submitted
29 Sep 2016
Last updated
3 Mar 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Chou S, Winston DJ, Avery RK, Cordonnier C, Duarte RF, Haider S, Maertens J, Peggs KS, Solano C, Young JH, Gu J, Pocock G, Papanicolaou GA. Comparative Emergence of Maribavir and Ganciclovir Resistance in a Randomized Phase 3 Clinical Trial for Treatment of Cytomegalovirus Infection. J Infect Dis. 2025 Mar 17;231(3):e470-e477. doi: 10.1093/infdis/jiae469.

    PubMed 39302855

  • Papanicolaou GA, Avery RK, Cordonnier C, Duarte RF, Haider S, Maertens J, Peggs KS, Solano C, Young JH, Fournier M, Murray RA, Wu J, Winston DJ; AURORA Trial Investigators. Treatment for First Cytomegalovirus Infection Post-Hematopoietic Cell Transplant in the AURORA Trial: A Multicenter, Double-Blind, Randomized, Phase 3 Trial Comparing Maribavir With Valganciclovir. Clin Infect Dis. 2024 Mar 20;78(3):562-572. doi: 10.1093/cid/ciad709.

    PubMed 38036487

  • Stewart AG, Kotton CN. What's New: Updates on Cytomegalovirus in Solid Organ Transplantation. Transplantation. 2024 Apr 1;108(4):884-897. doi: 10.1097/TP.0000000000004855. Epub 2023 Oct 30.

    PubMed 37899366

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Maribavir and Valganciclovir in people with Cytomegalovirus (CMV), run by Shire at 129 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 129 sites in United States, Spain, France, Germany, Belgium and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Achieved Confirmed Clearance of Plasma Cytomegalovirus (CMV) Deoxyribose Nucleic Acid (DNA) at the End of Study Week 8 (time frame: Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02927067, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in