Clinical trial NCT02931539: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cytomegalovirus (CMV)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2016-10-13
Enrollment: 352
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. The participant must be a recipient of hematopoietic stem cell or solid organ transplant.
3. 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.
4. 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.

   a. 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.
5. 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.
6. The participant must be \>= 12 years of age at the time of consent.
7. The participant must weigh \>= 35 kilogram (kg).
8. 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):

   1. Absolute neutrophil count (ANC) \>= 1000/ millimeter cube (mm\^3) (1.0 x 10\^9/liter \[L\])
   2. Platelet count \>= 25,000/mm\^3 \[25 x 10\^9/L\],
   3. Hemoglobin \>= 8 grams per deciliter (g/dL).
   4. 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.
9. 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.
10. The participant must be able to swallow tablets, or receive tablets crushed and/or dispensed in water via nasogastric or orogastric tube.
11. The participant must be willing and have an understanding and ability to fully comply with study procedures and restrictions defined in the protocol.
12. 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.
13. The participant must have a life expectancy of \>= 8 weeks.

Exclusion Criteria:

1. 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.
2. 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.
3. 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.
4. 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.
5. Have known hypersensitivity to the active substance or to an excipient for a study treatment.
6. Have tissue invasive CMV disease with central nervous system involvement including the retina (example, CMV retinitis).
7. 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.
8. 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.
9. Require mechanical ventilation or vasopressors for hemodynamic support at the time of enrollment.
10. Be female and pregnant or breast feeding.
11. Have previously received maribavir.
12. 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.
13. Have received any unapproved agent or device within 30 days before initiation of study treatment.
14. 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.
15. Be undergoing treatment for acute or chronic hepatitis C.
16. 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.

Primary outcomes:
measure: Percentage of Participants Who Achieved Confirmed Clearance of Plasma Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) (CMV Viremia Clearance) at End of Week 8
timeFrame: Week 8
Secondary outcomes:
measure: 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
timeFrame: Up to Week 16
measure: Percentage of Participants Who Achieved Confirmed CMV Viremia Clearance After Receiving 8 Weeks of Study-assigned Treatment
timeFrame: At Week 8 through Weeks 12, 16 and 20
measure: 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
timeFrame: At Week 8 through Weeks 12, 16 and 20
measure: 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
timeFrame: At Week 8 through Weeks 12 and 20
measure: 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
timeFrame: At Week 8
measure: 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
timeFrame: End of Week 8 up to Week 20 (12 weeks follow-up period)
measure: 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
timeFrame: Baseline up to Week 20
measure: Percentage of Participants Who Completed 8 Weeks of Study-assigned Treatment With Recurrence of CMV Viremia During the First 8 Weeks of the Treatment
timeFrame: Baseline up to Week 8
measure: Percentage of Participants Who Completed 8 Weeks of Study-assigned Treatment With Recurrence of CMV Viremia During the 12 Weeks of Follow-up Period
timeFrame: End of Week 8 up to Week 20 (12 weeks follow-up period)
measure: Percentage of Participants Who Completed 8 Weeks of Study-assigned Treatment With Recurrence of CMV Viremia During the 20 Weeks of Study
timeFrame: Baseline up to Week 20
measure: Percentage of Participants With Recurrence of CMV Viremia While on Study-assigned Treatment
timeFrame: Baseline up to termination of study treatment (up to Week 8)
measure: Percentage of Participants With Recurrence of CMV Viremia While Off Study-assigned Treatment During Follow-up Period
timeFrame: Termination of study treatment (Week 8) up to the End of the Study (Week 20)
measure: Number of Participants Who Had Maribavir CMV Resistance at Baseline
timeFrame: At Baseline
measure: Number of Participants Who Had Post-baseline Resistance to Maribavir
timeFrame: After first dose of study drug up to Week 20
measure: Number of Participants With All-cause Mortality by the End of the Study
timeFrame: From enrollment up to end of study (approximately 44 months)
measure: Time to All Cause Mortality
timeFrame: From enrollment to last serious adverse event (SAE) follow-up (approximately Week 28)
measure: Percentage of Participants Who Achieved Confirmed Clearance of Plasma CMV DNA (CMV Viremia Clearance) at End of Week 8 After Starting Maribavir Rescue Treatment
timeFrame: From start of maribavir rescue treatment through 8 weeks
measure: 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
timeFrame: Up to Week 16
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs During the On-treatment Observation Period
timeFrame: Baseline up to 7 days or 21 days (if cidofovir used) after the last dose of study treatment (up to Week 8)
measure: Predose Concentration (Cmin) of Maribavir
timeFrame: Predose at Week 1, 4 and 8
measure: Area Under the Concentration Time Curve Over the 12-hour Dosing Interval at Steady State (AUC0-tau) of Marivabir for Adolescent Participants
timeFrame: 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
measure: Maximum Plasma Concentration (Cmax) of Maribavir for Adolescent Participants
timeFrame: Week 1: Pre-morning dose and 1, 2, 3, 4, 6, 8 and 12 hours post morning dose
measure: Time When Maximum Concentration is Observed (Tmax) of Maribavir for Adolescent Participants
timeFrame: Week 1: Pre-morning dose and 1, 2, 3, 4, 6, 8 and 12 hours post morning dose
measure: Apparent Oral Clearance (CL/F) of Maribavir for Adolescent Participants
timeFrame: Week 1: Pre-morning dose and 1, 2, 3, 4, 6, 8 and 12 hours post morning dose
measure: Apparent Volume of Distribution (Vz/F) of Maribavir for Adolescent Participants
timeFrame: Week 1: Pre-morning dose and 1, 2, 3, 4, 6, 8 and 12 hours post morning dose
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Orlando
country: United States
facility: AdventHealth
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: Feinberg School of Medicine Northwestern University
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Maywood
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Womens Hospital
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic - PPDS
state: Minnesota
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital - Weill-Cornell
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center - PIN
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina - PPDS
state: South Carolina
city: Memphis
country: United States
facility: St Jude Children's Research Hospital
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Fort Worth
country: United States
facility: Baylor All Saints Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences Center - PPDS
state: Utah
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Clayton
country: Australia
facility: Monash Health, Monash Medical Centre
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Washington
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
city: Innsbruck
country: Austria
facility: Tiroler Landeskrankenanstalten GmbH
city: Wien
country: Austria
facility: Allgemeines Krankenhaus der Stadt Wien
city: Edegem
country: Belgium
facility: UZ Antwerpen
state: Antwerpen
city: Bruxelles
country: Belgium
facility: Institut Jules Bordet
state: Brussels
city: Gent
country: Belgium
facility: UZ Gent
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams Brabant
city: Brugge
country: Belgium
facility: AZ Sint-Jan AV
state: West-Vlaanderen
city: Antwerpen
country: Belgium
facility: ZNA Stuivenberg
city: Brussels
country: Belgium
facility: UZ Brussel
city: Bruxelles
country: Belgium
facility: Hôpital Erasme
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Corporation
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier Universitaire Sainte-Justine
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Center
state: Quebec
city: Zagreb
country: Croatia
facility: University Hospital Center Zagreb
city: København Ø
country: Denmark
facility: Copenhagen University Hospital
state: Capital
city: Brest
country: France
facility: CHRU Brest - Hospital Cavale Blanche
state: Finistère
city: Toulouse
country: France
facility: Hôpital de Rangueil
state: Haute-Garonne
city: Suresnes
country: France
facility: Hopital Foch
state: Hauts-de-Seine
city: Rennes
country: France
facility: CHRU Rennes
state: Ille-et-Vilaine
city: Tours
country: France
facility: CHRU Bretonneau
state: Indre-et-Loire
city: Nantes
country: France
facility: CHRU Nantes
state: Loire-Atlantique
city: Lyon
country: France
facility: Hôpital de La Croix Rousse
state: Rhône
city: Pierre-bénite
country: France
facility: Centre Hospitalier Lyon Sud
state: Rhône
city: Créteil
country: France
facility: Hopital Henri Mondor
state: Val-de-Marne
city: Villejuif
country: France
facility: Hôpital Paul Brousse
state: Val-de-Marne
city: AMIENS Cedex 1
country: France
facility: CHU Amiens Hôpital Sud
city: Amiens
country: France
facility: CHU Amiens Hôpital Sud
city: Clermont-Ferrand
country: France
facility: Hopital Gabriel Montpied
city: Grenoble
country: France
facility: CHU de GRENOBLE
city: Lille Cedex
country: France
facility: CHRU Lille
city: Limoges Cedex
country: France
facility: CHU Dupuytren
city: Lyon
country: France
facility: Groupement Hospitalier Edouard Herriot
city: Paris
country: France
facility: Groupe Hospitalier Necker Enfants Malades
city: Paris
country: France
facility: Hôpital Saint Louis
city: Paris
country: France
facility: Hôpital Saint Antoine
city: Poitiers
country: France
facility: CHRU de Poitiers La Miletrie
city: Saint-Priest en Jarez
country: France
facility: Institut de Cancerologie de la Loire
city: STRASBOURG Cedex
country: France
facility: Hôpital Civil
city: Strasbourg
country: France
facility: Hopital de Hautepierre
city: Heidelberg
country: Germany
facility: University Clinic Heidelberg - PPDS
state: Baden-Württemberg
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
state: Bayern
city: Essen
country: Germany
facility: Universitätsklinikum Essen
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
state: Rheinland-Pfalz
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig
state: Sachsen
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Heidelberg
country: Germany
facility: University Clinic Heidelberg - PPDS
city: München
country: Germany
facility: LMU Klinikum der Universität München
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Milano
country: Italy
facility: Ospedale San Raffaele S.r.l. - PPDS
state: Lombardia
city: Milano
country: Italy
facility: Istituto Europeo Di Oncologia
state: Lombardia
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
state: Marche
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitaria di Parma
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A Gemelli
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Integrata di Udine
city: Singapore
country: Singapore
facility: Singapore General Hospital (SGH)
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
state: Barcelona
city: Barakaldo
country: Spain
facility: Hospital Universitario de Cruces
city: Barcelona
country: Spain
facility: Fundacio Puigvert
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebrón - PPDS
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu i Sant Pau
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro - Majadahonda
city: Salamanca
country: Spain
facility: Complejo Asistencial Universitario de Salamanca - H. Clinico
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe de Valencia
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
state: Vaud (fr)
city: Coventry
country: United Kingdom
facility: University Hospital Coventry
state: Birmingham
city: West Midlands
country: United Kingdom
facility: Birmingham Heartlands Hospital
state: Birmingham
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre - PPDS
state: Glasgow City
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
state: London, City Of
city: Wythenshawe
country: United Kingdom
facility: Wythenshawe Hospital - PPDS
state: Manchester
city: Sheffield
country: United Kingdom
facility: Sheffield Childrens Hospital
state: Yorkshire
city: Liverpool
country: United Kingdom
facility: Royal Liverpool and Broadgreen University Hospitals NHS Trust
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary - PPDS
city: Oxford
country: United Kingdom
facility: Churchill Hospital
Study officials:
affiliation: Shire
name: Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.