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CMV DiseasePhase 3NCT03443869

Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients (MK-8228-002)

A Phase 3 study testing Letermovir, Valganciclovir and Acyclovir (ACV) in people with CMV Disease, run by Merck Sharp & Dohme LLC at 94 sites in 16 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 primary objective of this study is to evaluate the efficacy of letermovir (LET) versus valganciclovir (VGCV) in preventing CMV disease in adult kidney transplant recipients. The primary hypotheses are that LET is non-inferior to VGCV; and if non-inferiority is demonstrated, that LET is superior to VGCV, in… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
CMV Disease
What is being tested?
Letermovir, Valganciclovir and Acyclovir (ACV)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
601 participants
Where
94 sitesin 16 countries
Study dates
3 May 2018to 5 Apr 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have a documented negative serostatus for CMV within 180 days prior to randomization.
  • Anticipate receiving a primary or secondary allograft kidney from a CMV IgG seropositive (D+) donor at the time of screening AND have received a primary or secondary allograft kidney from a documented D+ donor at the time of randomization.
  • Be within 0 (i.e. day of transplantation) to 7 days (inclusive) post-kidney transplant at the time of randomization.
  • Males agree to use contraception during the treatment period, and for at least 90 days after the last dose of study treatment, and refrain from donating sperm during this period.
  • Female is not pregnant, not breastfeeding, and is not a woman of childbearing potential (WOCBP), OR if a WOCBP, agrees to follow the contraception guidance during the treatment period and for at least 90 days after the last dose of study treatment.

Who cannot join

  • Has received a previous solid organ transplant or hematopoietic stem cell transplant (HSCT). Note: Participants who have received a prior primary allograft kidney may be enrolled, provided that all other inclusion/exclusion criteria are met.
  • Is a multi-organ transplant recipient (e.g. kidney-pancreas). Double kidney transplant recipients (i.e. transplant of two kidneys from the same donor to the same recipient simultaneously) will be excluded.
  • Has a history of CMV disease or suspected CMV disease within 6 months prior to randomization.
  • Has suspected or known hypersensitivity to active or inactive ingredients of LET formulations, VGCV, GCV, and/or ACV formulations.
  • Is on dialysis or plasmapheresis at the time of randomization. Dialysis includes hemofiltration.
  • Has Child-Pugh Class C severe hepatic insufficiency at screening.
Show all 19Show fewer
  • Has both moderate hepatic insufficiency AND moderate-to-severe renal insufficiency at screening.
  • Has any uncontrolled infection on the day of randomization.
  • Has documented positive results for human immunodeficiency virus antibody (HIV-Ab) test at any time prior to randomization, or for hepatitis C virus antibody (HCV-Ab) and with detectable HCV ribonucleic acid (RNA) within 90 days prior to randomization, or hepatitis B surface antigen (HBsAg) within 90 days prior to randomization.
  • Requires mechanical ventilation, or is hemodynamically unstable, at the time of randomization.
  • Has a history of malignancy ≤5 years prior to signing informed consent.
  • Is pregnant or expecting to conceive, is breastfeeding, or plans to breastfeed from the time of consent through at least 90 days following cessation of study therapy.
  • Is expecting to donate eggs or sperm starting from the time of consent through at least 90 days following cessation of study therapy.
  • Has received within 30 days prior to randomization or plans to receive during the study any of the following anti-CMV IgG antibody treatment or anti-CMV drug therapy including the following: Cidofovir, CMV hyper-immune globulin, Any investigational CMV antiviral agent/biologic therapy.
  • Has received within 7 days prior to randomization or plans to receive during the study any of the following anti-CMV drug therapy: LET, GCV, VGCV, Foscarnet, ACV, Valacyclovir, Famciclovir.
  • Is a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence.
  • Is currently participating or has participated in a study with an unapproved investigational compound or device within 28 days, or 5× half-life of the investigational compound whichever is longer, of initial dosing on this study.
  • Has previously participated in this study or any other study involving LET.
  • Has previously participated or is currently participating in any study involving administration of a CMV vaccine or another CMV investigational agent, or is planning to participate in a study of a CMV vaccine or another CMV investigational agent during the course of this study.

Trial locations and contacts

94 sites in 16 countries.

94 sites in 16 countries

United States27 sites

  • The Emory Clinic ( Site 0247)

    Atlanta, Georgia, 30322

  • University of Maryland Medical Center ( Site 0234)

    Baltimore, Maryland, 21201

  • Johns Hopkins Hospital ( Site 0232)

    Baltimore, Maryland, 21287

  • UAB ( Site 0269)

    Birmingham, Alabama, 35233

  • Brigham & Women's Hospital ( Site 0244)

    Boston, Massachusetts, 02115

  • Medical University of South Carolina ( Site 0257)

    Charleston, South Carolina, 29425

  • University of Chicago ( Site 0251)

    Chicago, Illinois, 60637

  • The Ohio State University Wexner Medical Center ( Site 0264)

    Columbus, Ohio, 43210

  • Henry Ford Hospital ( Site 0242)

    Detroit, Michigan, 48202

  • Duke University Medical Center ( Site 0243)

    Durham, North Carolina, 27710

  • Indiana University ( Site 0261)

    Indianapolis, Indiana, 46202

  • Saint Barnabas Medical Center ( Site 0250)

    Livingston, New Jersey, 07039

  • UCLA Medical Center ( Site 0266)

    Los Angeles, California, 90095

  • Vanderbilt University Medical Center ( Site 0275)

    Nashville, Tennessee, 37232

  • Ochsner Clinic Foundation ( Site 0238)

    New Orleans, Louisiana, 70121

  • Icahn School of Medicine at Mount Sinai ( Site 0256)

    New York, New York, 10029

  • Columbia University Medical Center ( Site 0255)

    New York, New York, 10032

  • New York Presbyterian Hospital - Weill Cornell Medical Center ( Site 0276)

    New York, New York, 10065

  • University of Nebraska Medical Center ( Site 0272)

    Omaha, Nebraska, 68198

  • University of Pennsylvania ( Site 0270)

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh ( Site 0252)

    Pittsburgh, Pennsylvania, 15213

  • Virginia Commonwealth University ( Site 0245)

    Richmond, Virginia, 23298

  • UC Davis Medical Center ( Site 0271)

    Sacramento, California, 95817

  • University of California-San Francisco ( Site 0236)

    San Francisco, California, 94143

  • University of Washington Medical Center ( Site 0246)

    Seattle, Washington, 98195

  • Stanford Health Care ( Site 0235)

    Stanford, California, 94305

  • Wake Forest University Baptist Medical Center ( Site 0260)

    Winston-Salem, North Carolina, 27157

Other trials in United States

Colombia8 sites

  • Clinica del Country ( Site 0208)

    Bogotá, Bogota D.C., 110221

  • Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 0209)

    Bogotá, Bogota D.C., 110311

  • Hospital Universitario Mayor Mederi CIMED ( Site 0206)

    Bogotá, Bogota D.C., 110911

  • Sociedad de Cirugia de Bogota Hospital de San Jose ( Site 0203)

    Bogotá, Bogota D.C., 111411

  • Fundacion Cardiovascular de Colombia ( Site 0210)

    Bucaramanca, Santander Department, 680003

  • Fundacion Valle del Lili ( Site 0285)

    Cali, Valle del Cauca Department, 760032

  • Centro Medico Imbanaco de Cali S.A ( Site 0201)

    Cali, Valle del Cauca Department, 760042

  • Hospital San Vicente Fundación - Rionegro ( Site 0205)

    Rionegro, Antioquia, 054047

Other trials in Colombia

France7 sites

  • CHU de Bordeaux. Hopital Pellegrin ( Site 0055)

    Bordeaux, Gironde, 33076

  • Hopital Henri Mondor du Creteil ( Site 0063)

    Créteil, Val-de-Marne, 94000

  • CHU - Hopital de Bicetre ( Site 0060)

    Le Kremlin-Bicêtre, Val-de-Marne, 94270

  • Hopital Pasteur ( Site 0053)

    Nice, Alpes-Maritimes, 51069

  • Hopital Tenon ( Site 0061)

    Paris, 75020

  • CHU Rangueil ( Site 0054)

    Toulouse, Haute-Garonne, 31059

  • C.H.R.U Bretonneau ( Site 0051)

    Tours, Indre-et-Loire, 44093

Other trials in France

Argentina6 sites

  • CEMIC ( Site 0352)

    Buenos Aires, Buenos Aires F.D., C1431FWO

  • Instituto de Nefrologia Nephrology S.A. ( Site 0182)

    Buenos Aires, C1425APQ

  • Hospital Italiano de Buenos Aires ( Site 0188)

    CABA, C1199ABD

  • Instituto de Cardiología de Corrientes Juana F. Cabral ( Site 0181)

    Corrientes, W3400AMZ

  • Hospital El Cruce Nestor Carlos Kirchner ( Site 0351)

    San Juan Bautista, Buenos Aires, B1073ABA

  • Clinica de nefrologia urologia y enfermedades cardiovasculares ( Site 0354)

    Santa Fe, S3000BPJ

Other trials in Argentina

Australia6 sites

  • Royal Adelaide Hospital ( Site 0003)

    Adelaide, South Australia, 5000

  • Royal Prince Alfred Hospital ( Site 0005)

    Camperdown, New South Wales, 2050

  • Monash Health-Monash Medical Centre ( Site 0008)

    Clayton, Victoria, 3168

  • Royal Melbourne Hospital ( Site 0007)

    Parkville, Victoria, 3050

  • Westmead Hospital ( Site 0006)

    Westmead, New South Wales, 2145

  • Princess Alexandra Hospital ( Site 0004)

    Woolloongabba, Queensland, 4102

Other trials in Australia

Spain6 sites

  • Hospital del Mar ( Site 0121)

    Barcelona, La Coruna, 08003

  • Hospital Universitari Vall de Hebron ( Site 0112)

    Barcelona, 08035

  • Hospital Clinic i Provincial de Barcelona ( Site 0113)

    Barcelona, 08036

  • Hospital Universitari de Bellvitge IDIBELL ( Site 0114)

    L'Hospitalet de Llobregat, La Coruna, 08907

  • Hospital Doce de Octubre ( Site 0116)

    Madrid, 28041

  • Hospital Universitario Miguel Servet ( Site 0118)

    Zaragoza, 50009

Other trials in Spain

Canada5 sites

  • University of Alberta Hospital ( Site 0221)

    Edmonton, Alberta, T6G 2B7

  • Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0226)

    Montreal, Quebec, H1T 2M4

  • Toronto General Hospital ( Site 0222)

    Toronto, Ontario, M5G 2N2

  • Vancouver General Hospital ( Site 0224)

    Vancouver, British Columbia, V5Z 1M9

  • St. Paul's Hospital ( Site 0225)

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

Mexico5 sites

  • Centenario Hospital Miguel Hidalgo ( Site 0215)

    Aguascalientes, 20259

  • Instituto Mexicano de Trasplantes S C ( Site 0212)

    Cuernavaca, Morelos, 62448

  • Instituto Nacional de Cardiologia Ignacio Chavez ( Site 0213)

    Mexico City, 14080

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0214)

    Mexico City, 14080

  • Faicic S de RL de CV ( Site 0211)

    Veracruz, 91900

Other trials in Mexico

Poland5 sites

  • Uniwersyteckie Centrum Kliniczne ( Site 0170)

    Gdansk, Pomeranian Voivodeship, 80-952

  • Szpital Wojewodzki w Poznaniu ( Site 0168)

    Poznan, Greater Poland Voivodeship, 60-479

  • Pomorski Uniwersytet Medyczny ( Site 0167)

    Szczecin, West Pomeranian Voivodeship, 70-111

  • Szpital Kliniczny Dzieciatka Jezus ( Site 0165)

    Warsaw, Masovian Voivodeship, 02-006

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 0162)

    Wroclaw, Lower Silesian Voivodeship, 50-556

Other trials in Poland

Hungary4 sites

  • Semmelweis Egyetem ( Site 0281)

    Budapest, 1082

  • Debreceni Egyetem. ( Site 0283)

    Debrecen, 4032

  • Pecsi Tudomanyegyetem AOK ( Site 0282)

    Pécs, Baranya, 7624

  • Szegedi Tudomanyegyetem ( Site 0284)

    Szeged, Csongrád megye, 6725

Other trials in Hungary

Italy4 sites

  • IRCCS Ospedale San Raffaele di Milano ( Site 0098)

    Milan, 20132

  • Azienda Ospedaliera di Padova U.O.C. Trapianti Rene e Pancreas ( Site 0091)

    Padova, Veneto, 35128

  • Policlinico Gemelli Instituto di Clinica Chirurgica ( Site 0093)

    Roma, 00168

  • A.O.U. Citta della Salute e della Scienza di Torino ( Site 0096)

    Turin, Piedmont, 10126

Other trials in Italy

Belgium3 sites

  • Cliniques Universitaires de Bruxelles - CUB - Hopital Erasme ( Site 0042)

    Brussels, Bruxelles-Capitale, Region de, 1070

  • Universitair Ziekenhuis Antwerpen ( Site 0041)

    Edegem, Antwerpen, 2650

  • UZ Leuven - Campus Gasthuisberg ( Site 0044)

    Leuven, Vlaams-Brabant, 3000

Other trials in Belgium

Germany3 sites

  • Charite Universitaetsmedizin Berlin ( Site 0071)

    Berlin, 10117

  • Universitaetsklinikum Essen ( Site 0074)

    Essen, North Rhine-Westphalia, 45147

  • Medizinische Hochschule Hannover ( Site 0073)

    Hanover, Lower Saxony, 30625

Other trials in Germany

Austria2 sites

  • Medizinische Universitat Innsbruck ( Site 0033)

    Innsbruck, Tyrol, 6020

  • Allgemeines Krankenhaus Universitaetskliniken Wien ( Site 0032)

    Vienna, 1090

Other trials in Austria

United Kingdom2 sites

  • Queen Elizabeth Hospital ( Site 0356)

    Birmingham, B15 2GW

  • St Georges University Hospitals NHS Foundation Trust. ( Site 0136)

    London, London, City of, SW17 0QT

Other trials in United Kingdom

New Zealand1 site

  • Auckland City Hospital ( Site 0002)

    Auckland, 1142

Other trials in New Zealand

About this study

Official title: A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of MK-8228 (Letermovir) Versus Valganciclovir for the Prevention of Human Cytomegalovirus (CMV) Disease in Adult Kidney Transplant Recipients

The primary objective of this study is to evaluate the efficacy of letermovir (LET) versus valganciclovir (VGCV) in preventing CMV disease in adult kidney transplant recipients. The primary hypotheses are that LET is non-inferior to VGCV; and if non-inferiority is demonstrated, that LET is superior to VGCV, in preventing CMV disease through 52 weeks post-transplant.

Conditions
CMV Disease
Being tested
Letermovir, Valganciclovir, Acyclovir (ACV), Placebo to ACV, Placebo to LET

What participants receive

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

  • LetermovirDrug

    LET 480mg (or 240 mg when administered concomitantly with cyclosporin A) once daily for 28 weeks

  • ValganciclovirDrug

    900 mg VGCV tablet orally, once daily for 28 weeks

  • Acyclovir (ACV)Drug

    400 mg over-encapsulated ACV tablet orally, every 12 hours for 28 weeks

  • Placebo to ACVDrug

    Over-encapsulated placebo tablet orally, every 12 hours for 28 weeks

  • Placebo to LETDrug

    Placebo to LET tablet orally, once daily for 28 weeks

  • Placebo to VGCVDrug

    Placebo to VGCV tablet orally, once daily for 28 weeks

Study groups in NCT03443869
Study groupRoleWhat they receive
LetermovirExperimentalLET 480mg (or 240 mg when administered concomitantly with cyclosporin A) tablet orally; placebo to VGCV tablet orally once daily; and 400 mg capsule of acyclovir (ACV) orally every 12 hours for 28 weeks
Receives: Drug: Letermovir; Drug: Acyclovir (ACV); Drug: Placebo to VGCV
ValganciclovirActive comparator900 mg VGCV tablet orally, once daily; placebo to LET tablet orally once daily; and placebo to ACV orally every 12 hours for 28 weeks
Receives: Drug: Valganciclovir; Drug: Placebo to ACV; Drug: Placebo to LET

What is being measured

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

  1. Percentage of Participants With Adjudicated Cytomegalovirus (CMV) Disease Through 52 Weeks Post-transplant

    CMV disease was defined as the presence of either CMV end-organ disease or CMV syndrome and was confirmed by an independent, blinded Clinical Adjudication Committee (CAC). Only CAC-confirmed ("adjudicated") cases were included in percentage of participants who met the endpoint. Investigator-assessed cases which were not confirmed by the CAC were not included.

    Measured: Up to 52 weeks

Secondary outcomes (4)

  1. Percentage of Participants With Adjudicated CMV Disease Through 28 Weeks Post-transplant

    CMV disease was defined as the presence of either CMV end-organ disease or CMV syndrome and was confirmed by an independent, blinded CAC. Only CAC-confirmed ("adjudicated") cases were included in percentage of participants who met the endpoint. Investigator-assessed cases which were not confirmed by the CAC were not included.

    Measured: Up to 28 weeks

  2. Time to Onset of Adjudicated CMV Disease Through 52 Weeks Post-transplant

    The time to onset of adjudicated CMV disease was calculated in days, from the day of randomization to the day of onset of CMV disease as determined by the CAC.

    Measured: Up to 52 weeks

  3. Percentage of Participants With Any AE

    An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE.

    Measured: Up to 52 weeks

  4. Percentage of Participants With Any Drug-related Serious Adverse Event (SAE)

    An SAE was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event. SAEs that the investigator determined the relationship of the AE to the treatment as at least possibly related were reported.

    Measured: Up to 52 weeks

Timeline

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

  1. First posted23 Feb 2018
  2. Study start3 May 2018
  3. Primary completion5 Apr 2022
  4. Study completion5 Apr 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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
601 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03443869
Sponsor's protocol ID
8228-002
Other IDs
MK-8228-002, 2017-001055-30, 2017
Status last verified
Jul 2023
First submitted
19 Feb 2018
Last updated
28 Jul 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • Limaye AP, Budde K, Humar A, Vincenti F, Kuypers DRJ, Carroll RP, Stauffer N, Murata Y, Strizki JM, Teal VL, Gilbert CL, Haber BA. Letermovir vs Valganciclovir for Prophylaxis of Cytomegalovirus in High-Risk Kidney Transplant Recipients: A Randomized Clinical Trial. JAMA. 2023 Jul 3;330(1):33-42. doi: 10.1001/jama.2023.9106.

    PubMed 37279999

  • Bunnapradist S, Vincenti F, Witzke O, Schneeberger S, Nguyen MH, Broyde N, Gilbert CL, Haber B. Favorable Adherence and Tolerability of Letermovir Versus Valganciclovir for Cytomegalovirus Prophylaxis in Kidney Transplant Recipients Aged 65 y or Older: Findings From a Randomized, Phase 3 Trial. Transplant Direct. 2026 Aug 21;12(9):e1990. doi: 10.1097/TXD.0000000000001990. eCollection 2026 Sep.

    PubMed 42639594

  • Limaye AP, Crespo M, Kamar N, Humar A, Carroll RP, Pereira MR, Broyde N, Wang W, Haber B. Cytomegalovirus (CMV)-Specific Cell-Mediated Immunity for Prediction of Postprophylaxis CMV Disease in a Phase 3 Trial of Letermovir Versus Valganciclovir Prophylaxis in Donor CMV-Seropositive/Recipient CMV-Seronegative Kidney Transplant Recipients. Clin Infect Dis. 2026 Feb 25;82(2):e316-e324. doi: 10.1093/cid/ciaf632.

    PubMed 41321121

  • Strizki JM, Diamond TL, Teal VL, Gilbert CL, Wang W, Stauffer N, Haber BA. Cytomegalovirus Antiviral Resistance Among Kidney Transplant Recipients in a Phase 3 Trial of Letermovir vs Valganciclovir Prophylaxis. J Infect Dis. 2024 Dec 16;230(6):e1287-e1298. doi: 10.1093/infdis/jiae287.

    PubMed 38853607

  • Vernooij RW, Michael M, Ladhani M, Webster AC, Strippoli GF, Craig JC, Hodson EM. Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2024 May 3;5(5):CD003774. doi: 10.1002/14651858.CD003774.pub5.

    PubMed 38700045

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Letermovir, Valganciclovir and Acyclovir (ACV) in people with CMV Disease, run by Merck Sharp & Dohme LLC at 94 sites in 16 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 5 inclusion and 19 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 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in United States, Colombia, France, Argentina, Australia and 11 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 14 Apr 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?

Percentage of Participants With Adjudicated Cytomegalovirus (CMV) Disease Through 52 Weeks Post-transplant (time frame: Up to 52 weeks). 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 NCT03443869, which also lists 5 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 28 Jul 2023.

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