AzTrials
AzTrials

Cytomegalovirus (CMV)Phase 3NCT02931539

Efficacy and Safety Study of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir

A Phase 3 study testing Maribavir, Ganciclovir and Valganciclovir in people with Cytomegalovirus (CMV), run by Shire at 134 sites in 14 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

The purpose of this study is to compare the efficacy of maribavir to investigator-assigned anti-Cytomegalovirus (CMV) therapy in CMV viremia clearance in transplant recipients who are refractory or resistant to prior anti-CMV treatment. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Cytomegalovirus (CMV)
What is being tested?
Maribavir, Ganciclovir and Valganciclovir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
352 participants
Where
134 sitesin 14 countries
Study dates
22 Dec 2016to 17 Aug 2020
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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • The participant must 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 participant before completing any study-related procedures.
  • The participant must be a recipient of hematopoietic stem cell or solid organ transplant.
  • The participant must have a documented CMV infection in whole blood or plasma, with a screening value of greater than or equal to (>=) 2730 international units per milliliter (IU/mL) in whole blood or >= 910 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. The same laboratory and same sample type (whole blood or plasma) must be used for these assessments.
  • The participant must have a current CMV infection that is refractory to the most recently administered of the four anti-CMV treatment agents. Refractory is defined as documented failure to achieve greater than (>) 1 log10 (common logarithm to base 10) decrease in CMV DNA level in whole blood or plasma after a 14 day or longer treatment period with intravenous (IV) ganciclovir/oral valganciclovir, IV foscarnet, or IV cidofovir.
  • Participants with documentation of 1 or more CMV genetic mutations associated with resistance to ganciclovir/valganciclovir, foscarnet, and/or cidofovir must also meet the definition of refractory CMV infection.
  • The Investigator must be willing to treat the participant with at least one of the available anti-CMV drugs (ganciclovir, valganciclovir, foscarnet, or cidofovir). Note: Combination therapy with foscarnet and cidofovir is not permitted in the investigator-assigned anti-CMV treatment (IAT) arm due to the potential for serious nephrotoxicity.
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  • The participant must be >= 12 years of age at the time of consent.
  • The participant must weigh >= 35 kilogram (kg).
  • The participant must 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 (ANC) >= 1000/ millimeter cube (mm^3) (1.0 x 10^9/liter [L])
  • Platelet count >= 25,000/mm^3 [25 x 10^9/L],
  • Hemoglobin >= 8 grams per deciliter (g/dL).
  • Estimated glomerular filtration rate (eGFR) > 30 (milliliters per minute (mL/min) /1.73 square meter (m^2) as assessed by Modification of Diet in Renal Disease (MDRD) formula for participants >= 18 years of age or Schwartz formula for participants less than (<) 18 years of age.
  • The participant must have a negative serum beta-human chorionic gonadotropin (beta-HCG) pregnancy test at screening, if a female of child bearing potential. Additional urine pregnancy tests may be done per institutional requirements. 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 if treated with maribavir, ganciclovir, valganciclovir, or cidofovir and for 180 days afterward if treated with foscarnet.
  • The participant must be able to swallow tablets, or receive tablets crushed and/or dispensed in water via nasogastric or orogastric tube.
  • The participant must be willing and have an understanding and ability to fully comply with study procedures and restrictions defined in the protocol.
  • The participant must be willing to provide necessary samples (example [e.g,] biopsy) for the diagnosis of tissue invasive CMV disease at baseline as determined by the Investigator.
  • The participant must have a life expectancy of >= 8 weeks.

Who cannot join

  • Have a current CMV infection that is considered refractory or resistant due to inadequate adherence to prior anti-CMV treatment, to the best knowledge of the Investigator.
  • Require ganciclovir, valganciclovir, foscarnet, or cidofovir administration for conditions other than CMV when study treatment is initiated (example: herpes simplex virus (HSV) coinfection requiring use of any of these agents after the randomization) or would need a coadministration with maribavir for CMV infection. NOTE: A participant who is not continuing with the same anti-CMV drug(s) (ganciclovir, valganciclovir or foscarnet) for the study treatment (if randomized to the investigator assigned anti-CMV treatment arm), must discontinue their use before the first dose of study drug. If participant is currently being treated with cidofovir and is assigned another anti-CMV therapy by the investigator, the participant must discontinue its use at least 14 days prior to randomization at Visit 2/Day 0 and the first dose of study treatment.
  • Be receiving leflunomide, letermovir, or artesunate when study treatment is initiated. NOTE: Participants 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 at least 3 days prior to the first dose of study treatment. Participants receiving artesunate must discontinue the use prior to the first dose of study treatment.
  • 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/enteral medication.
  • Have known hypersensitivity to the active substance or to an excipient for a study treatment.
  • Have tissue invasive CMV disease with central nervous system involvement including the retina (example, CMV retinitis).
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  • Have serum aspartate aminotransferase (AST) > 5 times upper limit of normal (ULN) at screening, or serum alanine aminotransferase (ALT) > 5 times ULN at screening, or total bilirubin >= 3.0 x ULN at screening (except for documented Gilbert's syndrome), by local or central lab. Participants with biopsy confirmed CMV hepatitis will not be excluded from study participation despite AST or ALT > 5 times ULN at screening.
  • Have known 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.
  • Require mechanical ventilation or vasopressors for hemodynamic support at the time of enrollment.
  • Be female and pregnant or breast feeding.
  • Have previously received maribavir.
  • Have received any investigational agent with known anti-CMV activity within 30 days before initiation of study treatment or investigational CMV vaccine at any time.
  • Have received any unapproved agent or device within 30 days before initiation of study treatment.
  • Have active malignancy with the exception of nonmelanoma skin cancer. Participants who have had a hematopoietic stem cell transplant (HSCT) and who experience relapse or progression of the malignancy as per investigator's opinion are not to be enrolled.
  • Be undergoing treatment for acute or chronic hepatitis C.
  • Have any clinically significant medical or surgical condition that, in the investigator's opinion, could interfere with the interpretation of study results, contraindicate the administration of the assigned study treatment, or compromise the safety or well-being of the participant.

Trial locations and contacts

134 sites in 14 countries.

134 sites in 14 countries

United States47 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • University of Maryland

    Baltimore, Maryland, 21201

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294-0006

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Womens Hospital

    Boston, Massachusetts, 02115

  • Medical University of South Carolina - PPDS

    Charleston, South Carolina, 29425

  • Feinberg School of Medicine Northwestern University

    Chicago, Illinois, 60611

  • The Christ Hospital

    Cincinnati, Ohio, 45220

  • University of Cincinnati

    Cincinnati, Ohio, 45220

  • Cincinnati Children's Hospital Medical Center - PIN

    Cincinnati, Ohio, 45229-3039

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Duke University Medical Center

    Durham, North Carolina, 27710-4000

  • Baylor All Saints Medical Center

    Fort Worth, Texas, 76104

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Baylor College of Medicine

    Houston, Texas, 77030-2348

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Kentucky

    Lexington, Kentucky, 40536

  • University of Southern California

    Los Angeles, California, 90033

  • UCLA Medical Center

    Los Angeles, California, 90095

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • University of Chicago Medical Center

    Maywood, Illinois, 60153

  • St Jude Children's Research Hospital

    Memphis, Tennessee, 38105

  • University of Minnesota

    Minneapolis, Minnesota, 55454

  • Yale University School of Medicine

    New Haven, Connecticut, 06520

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Columbia University Medical Center

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • New York Presbyterian Hospital - Weill-Cornell

    New York, New York, 10065

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-5400

  • AdventHealth

    Orlando, Florida, 32804

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Mayo Clinic - PPDS

    Rochester, Minnesota, 59905

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • UC Davis Medical Center

    Sacramento, California, 95817

  • University of Utah Health Sciences Center - PPDS

    Salt Lake City, Utah, 84132

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Stanford University

    Stanford, California, 94305

  • SUNY Upstate Medical Center

    Syracuse, New York, 13210

  • University of Arizona

    Tucson, Arizona, 85724

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

France23 sites

  • CHU Amiens Hôpital Sud

    Amiens, 80054

  • CHRU Brest - Hospital Cavale Blanche

    Brest, Finistère, 29609

  • Hopital Gabriel Montpied

    Clermont-Ferrand, 63003

  • Hopital Henri Mondor

    Créteil, Val-de-Marne, 94010

  • CHU de GRENOBLE

    Grenoble, 38043

  • CHRU Lille

    Lille, 59037

  • CHU Dupuytren

    Limoges, 87042

  • Hôpital de La Croix Rousse

    Lyon, Rhône, 69004

  • Groupement Hospitalier Edouard Herriot

    Lyon, 69437

  • CHRU Nantes

    Nantes, Loire-Atlantique, 44093

  • Groupe Hospitalier Necker Enfants Malades

    Paris, 75015

  • Hôpital Saint Louis

    Paris, 75475

  • Hôpital Saint Antoine

    Paris, 75571

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, Rhône, 69495

  • CHRU de Poitiers La Miletrie

    Poitiers, 86000

  • CHRU Rennes

    Rennes, Ille-et-Vilaine, 35033

  • Institut de Cancerologie de la Loire

    Saint-Priest-en-Jarez, 42271

  • Hopital de Hautepierre

    Strasbourg, 67091

  • Hôpital Civil

    Strasbourg, 67091

  • Hopital Foch

    Suresnes, Hauts-de-Seine, 92150

  • Hôpital de Rangueil

    Toulouse, Haute-Garonne, 31059

  • CHRU Bretonneau

    Tours, Indre-et-Loire, 37044

  • Hôpital Paul Brousse

    Villejuif, Val-de-Marne, 94800

Other trials in France

United Kingdom11 sites

  • University Hospital Coventry

    Coventry, Birmingham, CV2 2DX

  • Beatson West of Scotland Cancer Centre - PPDS

    Glasgow, Glasgow City, G12 0YN

  • Royal Liverpool and Broadgreen University Hospitals NHS Trust

    Liverpool, L7 8XP

  • Imperial College Healthcare NHS Trust

    London, London, City of, W12 0HS

  • Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital

    London, NW3 2QG

  • Royal Free Hospital

    London, NW3 2QG

  • Manchester Royal Infirmary - PPDS

    Manchester, M13 9WL

  • Churchill Hospital

    Oxford, OX3 7LJ

  • Sheffield Childrens Hospital

    Sheffield, Yorkshire, S10 2TH

  • Birmingham Heartlands Hospital

    West Midlands, Birmingham, B9 5SS

  • Wythenshawe Hospital - PPDS

    Wythenshawe, Manchester, M23 9LT

Other trials in United Kingdom

Spain10 sites

  • Hospital Universitario Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Universitario de Cruces

    Barakaldo, 48903

  • Fundacio Puigvert

    Barcelona, 08025

  • Hospital Universitario Vall d'Hebrón - PPDS

    Barcelona, 08035

  • Hospital de La Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, 08907

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Madrid, 28222

  • Complejo Asistencial Universitario de Salamanca - H. Clinico

    Salamanca, 37007

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

Other trials in Spain

Germany9 sites

  • Universitätsklinikum Erlangen

    Erlangen, Bavaria, 91054

  • Universitätsklinikum Erlangen

    Erlangen, 91054

  • Universitätsklinikum Essen

    Essen, North Rhine-Westphalia, 45122

  • University Clinic Heidelberg - PPDS

    Heidelberg, Baden-Wurttemberg, 69120

  • University Clinic Heidelberg - PPDS

    Heidelberg, 69120

  • Universitatsklinikum Leipzig

    Leipzig, Saxony, 04103

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, Rhineland-Palatinate, 55101

  • LMU Klinikum der Universität München

    München, 81377

  • Universitätsklinikum Tübingen

    Tübingen, 72076

Other trials in Germany

Belgium8 sites

  • ZNA Stuivenberg

    Antwerp, 2060

  • AZ Sint-Jan AV

    Bruges, West-Vlaanderen, 8000

  • Institut Jules Bordet

    Brussels, Brussels Capital, 1000

  • Hôpital Erasme

    Brussels, 1070

  • UZ Brussel

    Brussels, 1090

  • UZ Antwerpen

    Edegem, Antwerpen, 2650

  • UZ Gent

    Ghent, Oost-Vlaanderen, 9000

  • UZ Leuven

    Leuven, Vlaams Brabant, 3000

Other trials in Belgium

Canada7 sites

  • University of Alberta

    Edmonton, Alberta, T6G 2G3

  • Hamilton Health Sciences Corporation

    Hamilton, Ontario, L8N 3Z5

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

  • Centre Hospitalier Universitaire Sainte-Justine

    Montreal, Quebec, H3T 1C5

  • McGill University Health Center

    Montreal, Quebec, H4A 3J1

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • University Health Network

    Toronto, Ontario, M5G 2N2

Other trials in Canada

Italy7 sites

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi

    Ancona, The Marches, 60126

  • Ospedale San Raffaele S.r.l. - PPDS

    Milan, Lombardy, 20132

  • Istituto Europeo Di Oncologia

    Milan, Lombardy, 20141

  • Azienda Ospedaliero Universitaria di Parma

    Parma, 43126

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56216

  • Fondazione Policlinico Universitario A Gemelli

    Roma, 00168

  • Azienda Sanitaria Universitaria Integrata di Udine

    Udine, 12345

Other trials in Italy

Australia6 sites

  • Princess Alexandra Hospital

    Brisbane, 4102

  • Monash Health, Monash Medical Centre

    Clayton, Victoria, 3168

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Sir Charles Gairdner Hospital

    Nedlands, Washington, 6009

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Austria2 sites

  • Tiroler Landeskrankenanstalten GmbH

    Innsbruck, 6020

  • Allgemeines Krankenhaus der Stadt Wien

    Vienna, 1090

Other trials in Austria

Croatia1 site

  • University Hospital Center Zagreb

    Zagreb, 10000

Other trials in Croatia

Denmark1 site

  • Copenhagen University Hospital

    København Ø, Capital, 2100

Other trials in Denmark

Singapore1 site

  • Singapore General Hospital (SGH)

    Singapore, 169608

Other trials in Singapore

Switzerland1 site

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, Vaud (fr), 1011

Other trials in Switzerland

About this study

Official title: A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir

The purpose of this study is to compare the efficacy of maribavir to investigator-assigned anti-Cytomegalovirus (CMV) therapy in CMV viremia clearance in transplant recipients who are refractory or resistant to prior anti-CMV treatment.

Being tested
Maribavir, Ganciclovir, Valganciclovir, Foscarnet, Cidofovir

What participants receive

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

  • MaribavirDrug

    Also called SHP620

    Maribavir 400 milligrams (mg) (2x200 mg tablets) will be administered twice daily for 8 weeks.

  • GanciclovirDrug

    Ganciclovir as per the investigator's prescribed dosing regimen will be administered for 8 weeks.

  • ValganciclovirDrug

    Valganciclovir as per the investigator's prescribed dosing regimen will be administered for 8 weeks.

  • FoscarnetDrug

    Foscarnet as per the investigator's prescribed dosing regimen will be administered for 8 weeks.

  • CidofovirDrug

    Cidofovir as per the investigator's prescribed dosing regimen will be administered for 8 weeks.

Study groups in NCT02931539
Study groupRoleWhat they receive
Maribavir TreatmentExperimentalParticipants will receive 400 milligrams (mg) (2x200 mg tablets) maribavir twice daily orally (doses separated by a minimum of 8 hours) for 8 weeks.
Receives: Drug: Maribavir
Investigator-Assigned TreatmentActive comparatorParticipants will receive anti-CMV agent best suited to treat the respective participant as per the investigator's prescribed dosing regimen for 8 weeks. Agents of choice include: ganciclovir, valganciclovir, foscarnet, or cidofovir.
Receives: Drug: Ganciclovir; Drug: Valganciclovir; Drug: Foscarnet; Drug: Cidofovir

What is being measured

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

  1. Percentage of Participants Who Achieved Confirmed Clearance of Plasma Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) (CMV Viremia Clearance) at End of Week 8

    Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration less than (<) lower limit of quantification (LLOQ) that is, <137 International Units per milliliter (IU/mL) when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive postbaseline samples, separated by at least 5 days. Percentage of participants with confirmed CMV viremia clearance at end of study Week 8 regardless of whether either study-assigned treatment was discontinued before the end of the stipulated 8 weeks of therapy, and could not have received alternative anti-CMV treatment were reported.

    Measured: Week 8

Secondary outcomes (25)

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

    Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration <LLOQ that is, <137 IU/mL when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive postbaseline samples, separated by at least 5 days. CMV infection symptom control was defined as resolution or improvement of tissue invasive CMV disease or CMV syndrome for participants symptomatic at baseline, or maintaining no symptoms of tissue invasive CMV disease or CMV syndrome for participants asymptomatic at baseline. Percentage of participants who achieved CMV viremia clearance and CMV infection symptom control at end of Week 8 through Week 16 were reported.

    Measured: Up to Week 16

  2. Percentage of Participants Who Achieved Confirmed CMV Viremia Clearance After Receiving 8 Weeks of Study-assigned Treatment

    Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration <LLOQ that is, <137IU/mL when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive postbaseline samples, separated by at least 5 days. Percentage of participants who achieved confirmed CMV viremia clearance after receiving 8 weeks study-assigned treatment at end of Week 8, and maintained this effect through 12, 16 and 20 were reported.

    Measured: At Week 8 through Weeks 12, 16 and 20

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

    Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration <LLOQ that is, <137IU/mL when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive postbaseline samples, separated by at least 5 days. CMV infection symptom control was defined as resolution or improvement of tissue invasive CMV disease or CMV syndrome for participants symptomatic at baseline, or maintaining no symptoms of tissue invasive CMV disease or CMV syndrome for participants asymptomatic at baseline. Percentage of participants who achieved confirmed CMV viremia clearance and CMV infection control after receiving 8 weeks study-assigned treatment at end of Week 8, and maintained this effect through 12, 16 and 20 were reported.

    Measured: At Week 8 through Weeks 12, 16 and 20

  4. Percentage of Participants Who Maintained CMV Viremia Clearance and CMV Infection Symptom Control at the End of Study Week 8 Through Weeks 12 and 20 Regardless of Whether Either Study-assigned Treatment Was Discontinued Before 8 Weeks of Therapy

    Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration <LLOQ that is, <137IU/mL when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive postbaseline samples, separated by at least 5 days. CMV infection symptom control was defined as resolution or improvement of tissue invasive CMV disease or CMV syndrome for participants symptomatic at baseline or maintaining no symptoms of tissue invasive CMV disease or CMV syndrome for participants asymptomatic at baseline. Percentage of participants who maintained CMV viremia clearance and CMV infection symptom control at the end of study Week 8 through Weeks 12 and 20 regardless of whether either study-assigned treatment was discontinued before 8 weeks of therapy were reported.

    Measured: At Week 8 through Weeks 12 and 20

  5. Percentage of Participants With Recurrence of CMV Viremia During the First 8 Weeks of Study Regardless of Whether Study-assigned Treatment Was Discontinued Before 8 Weeks of Therapy

    Recurrence of CMV viremia was 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 achieving confirmed viremia clearance, regardless of whether either study-assigned treatment was discontinued before the end of the stipulated 8 weeks of therapy. Percentage of participants with recurrence of CMV viremia during the first 8 weeks of study regardless of whether study-assigned treatment was discontinued before 8 weeks of therapy were reported.

    Measured: At Week 8

  6. Percentage of Participants With Recurrence of CMV Viremia During the 12 Weeks Follow-up Period Regardless of Whether Study-assigned Treatment Was Discontinued Before 8 Weeks of Therapy

    Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance, regardless of whether either study-assigned treatment was discontinued before the end of the stipulated 8 weeks of therapy. Percentage of participants with recurrence of CMV viremia during the 12 weeks follow-up period regardless of whether study-assigned treatment was discontinued before 8 weeks of therapy were reported.

    Measured: End of Week 8 up to Week 20 (12 weeks follow-up period)

  7. Percentage of Participants With Recurrence of CMV Viremia at Any Time on Study Regardless of Whether Study-assigned Treatment Was Discontinued Before 8 Weeks of Therapy

    Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance, regardless of whether either study-assigned treatment was discontinued before the end of the stipulated 8 weeks of therapy. Percentage of participants with recurrence of CMV viremia during at any time on study regardless of whether study-assigned treatment was discontinued before 8 weeks of therapy were reported.

    Measured: Baseline up to Week 20

  8. Percentage of Participants Who Completed 8 Weeks of Study-assigned Treatment With Recurrence of CMV Viremia During the First 8 Weeks of the Treatment

    Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance. Percentage of participants with recurrence of CMV viremia during the first 8 Weeks of the treatment who completed 8 weeks of study-assigned treatment were reported.

    Measured: Baseline up to Week 8

  9. Percentage of Participants Who Completed 8 Weeks of Study-assigned Treatment With Recurrence of CMV Viremia During the 12 Weeks of Follow-up Period

    Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance. Percentage of participants who completed 8 weeks of study-assigned treatment with recurrence of CMV viremia during the 12 weeks of follow-up period were reported.

    Measured: End of Week 8 up to Week 20 (12 weeks follow-up period)

  10. Percentage of Participants Who Completed 8 Weeks of Study-assigned Treatment With Recurrence of CMV Viremia During the 20 Weeks of Study

    Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance. Percentage of participants with Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance. Percentage of participants who completed 8 weeks of study-assigned treatment with recurrence of CMV viremia during the 20 weeks of study were reported.

    Measured: Baseline up to Week 20

  11. Percentage of Participants With Recurrence of CMV Viremia While on Study-assigned Treatment

    Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance. Percentage of participants with recurrence of CMV viremia while on study-assigned treatment period were reported.

    Measured: Baseline up to termination of study treatment (up to Week 8)

  12. Percentage of Participants With Recurrence of CMV Viremia While Off Study-assigned Treatment During Follow-up Period

    Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance. Percentage of participants with recurrence of CMV viremia while off study-assigned treatment during follow-up period were reported.

    Measured: Termination of study treatment (Week 8) up to the End of the Study (Week 20)

  13. Number of Participants Who Had Maribavir CMV Resistance at Baseline

    Resistance-associated amino acid substitutions (RASs) to maribavir are known to generally map to the pUL97 and pUL27 genes. Genotyping was performed to identify RASs mapping to the pUL97 and pUL27 genes. Number of participants who had maribavir CMV resistance at baseline were reported.

    Measured: At Baseline

  14. Number of Participants Who Had Post-baseline Resistance to Maribavir

    Resistance-associated amino acid substitutions (RASs) to maribavir are known to generally map to the pUL97 and pUL27 genes. Genotyping was performed to identify RASs mapping to the pUL97 and pUL27 genes. Number of participants who had post-baseline resistance to maribavir were reported.

    Measured: After first dose of study drug up to Week 20

  15. Number of Participants With All-cause Mortality by the End of the Study

    All-cause mortality was analyzed by the end of study regardless of the use of rescue treatment or alternative anti-CMV treatment. Number of participants who died during the entire study period were reported.

    Measured: From enrollment up to end of study (approximately 44 months)

  16. Time to All Cause Mortality

    The time to all-cause mortality by the end of the study participation in days was calculated. Participants who were alive at the last study follow-up (regardless of use of rescue or alternative anti-CMV treatment), withdrew from study or were lost to follow-up were censored at the date of last contact.

    Measured: From enrollment to last serious adverse event (SAE) follow-up (approximately Week 28)

  17. Percentage of Participants Who Achieved Confirmed Clearance of Plasma CMV DNA (CMV Viremia Clearance) at End of Week 8 After Starting Maribavir Rescue Treatment

    Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration <LLOQ that is, <137 IU/mL when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive postbaseline samples, separated by at least 5 days, regardless of whether the rescue treatment was discontinued before the end of the stipulated 8 weeks of therapy. Percentage of participants who achieved confirmed CMV viremia clearance at end of Week 8 after starting maribavir rescue treatment were reported.

    Measured: From start of maribavir rescue treatment through 8 weeks

  18. Percentage of Participants Receiving Maribavir Rescue Treatment Who Achieved Confirmed CMV Viremia Clearance and CMV Infection Symptom Control at Week 8 With Maintenance of Effect Through Week 16

    Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration <LLOQ that is, <137 IU/mL when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive postbaseline samples, separated by at least 5 days. CMV infection symptom control was defined as resolution or improvement of tissue invasive CMV disease or CMV syndrome for participants symptomatic at baseline, or maintaining no symptoms of tissue invasive CMV disease or CMV syndrome for participants asymptomatic at baseline. Percentage of participants receiving maribavir rescue treatment who achieved confirmed CMV viremia clearance and CMV infection symptom control at Week 8 with maintenance of effect through Week 16 were reported.

    Measured: Up to Week 16

  19. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs During the On-treatment Observation Period

    An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Serious AE was any untoward medical occurrence (whether considered to be related to study-assigned treatment or not) that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital abnormality/birth defect, or was an important medical event. TEAEs was defined as any adverse events (classified by preferred term) that had a start date on or after the first dose of study treatment or that had a start date before the date of first dose of study treatment, but increased in severity after the first dose of study treatment.

    Measured: Baseline up to 7 days or 21 days (if cidofovir used) after the last dose of study treatment (up to Week 8)

  20. Predose Concentration (Cmin) of Maribavir

    Cmin of maribavir was reported.

    Measured: Predose at Week 1, 4 and 8

  21. Area Under the Concentration Time Curve Over the 12-hour Dosing Interval at Steady State (AUC0-tau) of Marivabir for Adolescent Participants

    AUC0-tau of maribavir for adolescent participants was planned to be reported.

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

  22. Maximum Plasma Concentration (Cmax) of Maribavir for Adolescent Participants

    Cmax of maribavir for adolescent participants was planned to be reported.

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

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

    Tmax of maribavir for adolescent participants was planned to be reported.

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

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

    Apparent oral clearance (CL/F) of maribavir for adolescent participants was planned to be reported.

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

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

    Apparent volume of distribution (Vz/F) of maribavir for adolescent participants was planned to be reported.

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

Timeline

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

  1. First posted13 Oct 2016 (estimated)
  2. Study start22 Dec 2016
  3. Primary completion17 Aug 2020
  4. Study completion17 Aug 2020

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
None (open label)
Enrolment
352 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02931539
Sponsor's protocol ID
SHP620-303
Other IDs
2015-004725-13, 2015
Status last verified
Sep 2021
First submitted
29 Sep 2016
Last updated
3 Nov 2021
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

  • Kamar N, Avery RK, Bo T, Gu J, Kumar D, Witzke O. Association Between Cytomegalovirus Viremia Clearance and Post-Solid Organ Transplant Mortality in Patients With Refractory Cytomegalovirus Infection: SOLSTICE Post Hoc Analysis. Transpl Int. 2025 Nov 26;38:15331. doi: 10.3389/ti.2025.15331. eCollection 2025.

    PubMed 41384277

  • Rajagopalan K, Bullano M, Gelone D, Bo T, Taduka V, Syed SS. Real-world effectiveness and tolerability of post solid organ transplant patients with CMV switching from valganciclovir treatment to maribavir: analysis using lab-linked claims data in the United States. Expert Rev Anti Infect Ther. 2025 Aug;23(8):653-662. doi: 10.1080/14787210.2025.2517344. Epub 2025 Jun 27.

    PubMed 40478680

  • Blumberg EA, Witzke O, Harber M, Ison MG, Saliba F, Kamar N, Sundberg AK, Gu J, Kumar D, La Hoz RM. Maribavir for refractory cytomegalovirus infection (with or without resistance) in solid organ transplant recipients: Subgroup analysis of the phase 3 randomized SOLSTICE study. J Heart Lung Transplant. 2025 Jun;44(6):986-994. doi: 10.1016/j.healun.2024.11.026. Epub 2024 Nov 28.

    PubMed 39613120

  • Sun K, Fournier M, Sundberg AK, Song IH. Maribavir: Mechanism of action, clinical, and translational science. Clin Transl Sci. 2024 Jan;17(1):e13696. doi: 10.1111/cts.13696.

    PubMed 38071422

  • Chou S, Alain S, Cervera C, Chemaly RF, Kotton CN, Lundgren J, Papanicolaou GA, Pereira MR, Wu JJ, Murray RA, Buss NE, Fournier M. Drug Resistance Assessed in a Phase 3 Clinical Trial of Maribavir Therapy for Refractory or Resistant Cytomegalovirus Infection in Transplant Recipients. J Infect Dis. 2024 Feb 14;229(2):413-421. doi: 10.1093/infdis/jiad293.

    PubMed 37506264

  • Avery RK, Alain S, Alexander BD, Blumberg EA, Chemaly RF, Cordonnier C, Duarte RF, Florescu DF, Kamar N, Kumar D, Maertens J, Marty FM, Papanicolaou GA, Silveira FP, Witzke O, Wu J, Sundberg AK, Fournier M; SOLSTICE Trial Investigators. Maribavir for Refractory Cytomegalovirus Infections With or Without Resistance Post-Transplant: Results From a Phase 3 Randomized Clinical Trial. Clin Infect Dis. 2022 Sep 10;75(4):690-701. doi: 10.1093/cid/ciab988.

    PubMed 34864943

  • Del Pozo Martin Y. 47th Annual Meeting of the EBMT. Lancet Haematol. 2021 May;8(5):e317-e318. doi: 10.1016/S2352-3026(21)00104-6. Epub 2021 Mar 31. No abstract available.

    PubMed 33811823

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Maribavir, Ganciclovir and Valganciclovir in people with Cytomegalovirus (CMV), run by Shire at 134 sites in 14 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 18 inclusion and 16 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 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 134 sites in United States, France, United Kingdom, Spain, Germany and 9 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 23 Sep 2021). 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?

Percentage of Participants Who Achieved Confirmed Clearance of Plasma Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) (CMV Viremia Clearance) at End of 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 NCT02931539, which also lists 7 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 Nov 2021.

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