Cytomegalovirus InfectionPhase 3NCT05763823

A Study of Letermovir (MK-8228) to Evaluate Efficacy and Safety for Prevention of Cytomegalovirus Infection in Chinese Hematopoietic Stem Cell Transplant Recipients (MK-8228-045)

A Phase 3 study testing Letermovir in people with Cytomegalovirus Infection, run by Merck Sharp & Dohme LLC at 21 sites in China.

Completed

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

Official record

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Trial summary

The purpose of this study is to evaluate the efficacy and safety of a once-a-day oral or intravenous (IV) dose of Letermovir (MK-8228) in Chinese adult hematopoietic stem cell transplant (HSCT) recipients for the prevention of clinically significant cytomegalovirus (CMV) infection. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cytomegalovirus Infection
What is being tested?: Letermovir
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 21 sitesChina
Study dates: 24 Mar 2023to 18 Apr 2024
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

Male/Female Chinese adult participant of an allogeneic Hematopoietic Stem Cell Transplant (HSCT).
Has documented positive Cytomegalovirus (CMV) serostatus (CMV immunoglobulin G [IgG] seropositive) for recipient (R+) at the time of screening.
Is receiving a first allogeneic HSCT.
Is within 28 days post-HSCT at the time of randomization.
Female participant is not a Woman of Child Bearing Potential (WOCBP) or is a WOBCP who agrees to use acceptable contraception during the treatment period and for ≥28 days after the last dose of study drug.

Who cannot join

Received a previous allogeneic HSCT.
Has a history of CMV end-organ disease within 6 months prior to randomization.
Has evidence of CMV viremia at any time from HSCT procedure until the time of randomization.
Has severe hepatic insufficiency.
Is a) on renal replacement therapy (e.g., hemodialysis, peritoneal dialysis) OR b) has end stage renal impairment with a creatinine clearance <=10 mL/min within 5 days prior to randomization.
Has both moderate hepatic insufficiency AND moderate to severe renal insufficiency.

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Has an uncontrolled infection on the day of randomization.
Has rapidly progressing disease that requires mechanical ventilation or is hemodynamically unstable.
Has a documented positive result for a human immunodeficiency virus antibody (HIV-Ab) test at any time prior to randomization, or for hepatitis C virus antibody (HCV-Ab) with detectable HCV ribonucleic acid (RNA), or hepatitis B surface antigen (HBsAg) within 90 days prior to randomization.
Has active solid tumor malignancies except localized basal cell or squamous cell skin cancer or the condition under treatment (e.g., lymphomas).
Has received any prohibited medications within 2 days prior to initiation of treatment with Letermovir.
Is anticipated to be treated with Traditional Chinese Medicine or herbal medicine during the study treatment period and for 14 days after study medication.

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

China21 sites

Peking University First Hospital ( Site 0009)
Beijing, Beijing Municipality, 100034
Peking University People's Hospital-Hematology ( Site 0033)
Beijing, Beijing Municipality, 100034
The First Hospital of Jilin University-Hematology ( Site 0023)
Changchun, Jilin, 130021
West China Hospital, Sichuan University ( Site 0008)
Chengdu, Sichuan, 610041
The General Hospital of Western Theater Command ( Site 0007)
Chengdu, Sichuan, 610083
The Second Affiliated Hospital of Third Military Medical University-Oncology Department ( Site 0002)
Chongqing, Chongqing Municipality, 400037
Southwest Hospital of Third Military Medical University ( Site 0005)
Chongqing, Chongqing Municipality, 400038
The Second Affiliated Hospital Chongqing Medical University ( Site 0013)
Chongqing, Chongqing Municipality, 400072
The 2nd Affiliated Hospital of Dalian Medical University ( Site 0019)
Dalian, Liaoning, 116023
Guangzhou First People's Hospital-Hematology Department ( Site 0001)
Guangzhou, Guangdong, 510180
Southern Medical University Nanfang Hospital ( Site 0003)
Guangzhou, Guangdong, 510515
The First Affiliated Hospital, Zhejiang University ( Site 0025)
Hangzhou, Zhejiang, 310003
Anhui Provincial Hospital ( Site 0024)
Hefei, Anhui, 230071
The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 0021)
Nanchang, Jiangxi, 330209
Shanghai General Hospital ( Site 0018)
Shanghai, Shanghai Municipality, 200080
Shenzhen Second People's Hospital-Hematology Department ( Site 0006)
Shenzhen, Guangdong, 518035
The First Affiliated Hospital of Soochow University-hematology department ( Site 0029)
Suzhou, Jiangsu, 215006
Institute of hematology&blood disease hospital-Hematology ( Site 0030)
Tianjin, Tianjin Municipality, 300020
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0028)
Wuhan, Hubei, 430022
Tongji Hospital Tongji Medical,Science & Technology ( Site 0032)
Wuhan, Hubei, 430030
The Affiliated Hospital of Xuzhou Medical College ( Site 0022)
Xuzhou, Jiangsu, 221006

Other trials in China

About this study

Official title: A Phase 3, Open Label, Single-Arm Clinical Trial to Evaluate the Efficacy and Safety of MK-8228 (Letermovir) for the Prevention of Clinically Significant Cytomegalovirus (CMV) Infection in Chinese Adult, CMV-Seropositive Allogeneic Hematopoietic Stem Cell Transplant Recipients

Conditions: Cytomegalovirus Infection
Being tested: Letermovir
Medical subject headings: Cytomegalovirus Infections

What participants receive

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

LetermovirDrug
Also called MK-8228
Daily 240 mg or 480 mg oral tablets or IV dose

Study groups in NCT05763823
Study group	Role	What they receive
Letermovir	Experimental	Chinese HSCT recipients will receive 240 mg of Letermovir [for participants on Cyclosporin A (CsA)] or 480 mg of Letermovir (for participants not on CsA) either orally or IV once daily through week 14 (~100 days) post-transplant. Receives: Drug: Letermovir

What is being measured

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

Percentage of Participants With Clinically Significant Cytomegalovirus (CMV) Infection up to Week 24 Post-Transplant
Clinically significant CMV infection was defined as either one of the following: 1) initiation of anti-CMV pre-emptive therapy based on documented CMV viremia and the clinical condition of the participant or 2) onset of CMV end-organ disease. The percentage of participants with clinically significant CMV infection up to week 24 post-transplant is reported.
Measured: Up to Week 24 post-transplant (approximately 6 months)

Secondary outcomes (9)

Percentage of Participants Who Experienced an Adverse Event (AE)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced an AE is reported.
Measured: Up to 16 weeks
Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinued study treatment due to an AE is reported.
Measured: Up to 14 weeks
Percentage of Participants With Clinically Significant CMV Infection up to Week 14 Post-Transplant
Clinically significant CMV infection was defined as either one of the following: 1) initiation of anti-CMV pre-emptive therapy based on documented CMV viremia and the clinical condition of the participant or 2) onset of CMV end-organ disease. The percentage of participants with clinically significant CMV infection up to 14 weeks post-transplant is reported.
Measured: Up to 14 weeks post-transplant (99 days)
Percentage of Participants With Preemptive Therapy for CMV Viremia up to Week 14 Post-Transplant
Initiation of anti-CMV preemptive therapy was based on documented CMV viremia and the clinical condition of the participant. The percentage of participants with initiation of anti-CMV preemptive anti-CMV therapy up to 14 weeks post-transplant is reported.
Measured: Up to 14 weeks post-transplant (99 days)
Percentage of Participants With Preemptive Therapy for CMV Viremia up to Week 24 Post-Transplant
Initiation of anti-CMV preemptive therapy was based on documented CMV viremia and the clinical condition of the participant. The percentage of participants with initiation of anti-CMV preemptive anti-CMV therapy up to 24 weeks post-transplant is reported.
Measured: Up to 24 weeks post-transplant (approximately 6 months)
Percentage of Participants With CMV End-organ Disease up to Week 14 Post-Transplant
CMV end-organ disease met per-protocol diagnostic criteria for CMV-pneumonia, gastrointestinal disease, hepatitis, central nervous system disease, retinitis, nephritis, cystitis, myocarditis, pancreatitis, or other disease categories. Only Clinical Adjudication Committee-confirmed CMV end-organ disease will be included in this analysis. The percentage of participants with CMV end-organ disease up to 14 weeks post-transplant is reported.
Measured: Up to 14 weeks post-transplant (99 days)
Percentage of Participants With CMV End-organ Disease up to Week 24 Post-Transplant
CMV end-organ disease met per-protocol diagnostic criteria for CMV-pneumonia, gastrointestinal disease, hepatitis, central nervous system disease, retinitis, nephritis, cystitis, myocarditis, pancreatitis, or other disease categories. Only Clinical Adjudication Committee-confirmed CMV end-organ disease will be included in this analysis. The percentage of participants with CMV end-organ disease up to 24 weeks post-transplant is reported.
Measured: Up to 24 weeks post-transplant (approximately 6 months)
Percentage of Participants With All-Cause Mortality up to Week 14 Post-Transplant
The percentage of participants who died due to any cause up to 14 weeks post-transplant is reported.
Measured: Up to 14 weeks post-transplant (99 days)
Percentage of Participants With All-cause Mortality up to Week 24 Post-Transplant
The percentage of participants who died due to any cause up to 24 weeks post-transplant is reported.
Measured: Up to 24 weeks post-transplant (approximately 6 months)

Timeline

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

24 Mar 202318 Apr 2024

First posted10 Mar 2023
Study start24 Mar 2023
Primary completion18 Apr 2024
Study completion18 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cytomegalovirus InfectionStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05763823
Sponsor's protocol ID: 8228-045
Other IDs: MK-8228-045
Status last verified: Feb 2025
First submitted: 28 Feb 2023
Last updated: 25 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
A Study of LIVTENCITY (Maribavir) in Adults With Cytomegalovirus (CMV) Infection After Transplantation in South Korea
Cytomegalovirus (CMV)
RecruitingObservational study
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
EBV, HSV
RecruitingPhase 1
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
Viral Infection
RecruitingPhase 2
CMV CTLs in Neonates With CMV Infection
Congenital Cytomegaloviral (CMV) Disease
RecruitingPhase 2
CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia

All Cytomegalovirus Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Open Label, Single-Arm Clinical Trial to Evaluate the Efficacy and Safety of MK-8228 (Letermovir) for the Prevention of Clinically Significant Cytomegalovirus (CMV) Infection in Chinese Adult, CMV-Seropositive Allogeneic Hematopoietic Stem Cell Transplant Recipients
ClinicalTrials.gov ID: NCT05763823
Acronym / sponsor ID: 8228-045
Conditions: Cytomegalovirus Infection
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 24 Mar 2023 (actual)
Primary completion: 18 Apr 2024 (actual)
Study completion: 18 Apr 2024 (actual)
First posted: 10 Mar 2023 (actual)
Results: Posted 25 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Letermovir	Experimental	Drug: LetermovirChinese HSCT recipients will receive 240 mg of Letermovir [for participants on Cyclosporin A (CsA)] or 480 mg of Letermovir (for participants not on CsA) either orally or IV once daily through week 14 (~100 days) post-transplant.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Male/Female Chinese adult participant of an allogeneic Hematopoietic Stem Cell Transplant (HSCT).
Has documented positive Cytomegalovirus (CMV) serostatus (CMV immunoglobulin G [IgG] seropositive) for recipient (R+) at the time of screening.
Is receiving a first allogeneic HSCT.
Is within 28 days post-HSCT at the time of randomization.
Female participant is not a Woman of Child Bearing Potential (WOCBP) or is a WOBCP who agrees to use acceptable contraception during the treatment period and for ≥28 days after the last dose of study drug.

Key exclusion criteria (12 listed)

Received a previous allogeneic HSCT.
Has a history of CMV end-organ disease within 6 months prior to randomization.
Has evidence of CMV viremia at any time from HSCT procedure until the time of randomization.
Has severe hepatic insufficiency.
Is a) on renal replacement therapy (e.g., hemodialysis, peritoneal dialysis) OR b) has end stage renal impairment with a creatinine clearance <=10 mL/min within 5 days prior to randomization.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LetermovirAlso: MK-8228Daily 240 mg or 480 mg oral tablets or IV dose	Drug	Letermovir

Primary outcome

Percentage of Participants With Clinically Significant Cytomegalovirus (CMV) Infection up to Week 24 Post-Transplant
Time frame: Up to Week 24 post-transplant (approximately 6 months)
Clinically significant CMV infection was defined as either one of the following: 1) initiation of anti-CMV pre-emptive therapy based on documented CMV viremia and the clinical condition of the participant or 2) onset of CMV end-organ disease. The percentage of participants with clinically significant CMV infection up to week 24 post-transplant is reported.

9 secondary outcomes

Percentage of Participants Who Experienced an Adverse Event (AE)
Time frame: Up to 16 weeks
Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event
Time frame: Up to 14 weeks
Percentage of Participants With Clinically Significant CMV Infection up to Week 14 Post-Transplant
Time frame: Up to 14 weeks post-transplant (99 days)
Percentage of Participants With Preemptive Therapy for CMV Viremia up to Week 14 Post-Transplant
Time frame: Up to 14 weeks post-transplant (99 days)
Percentage of Participants With Preemptive Therapy for CMV Viremia up to Week 24 Post-Transplant
Time frame: Up to 24 weeks post-transplant (approximately 6 months)
Percentage of Participants With CMV End-organ Disease up to Week 14 Post-Transplant
Time frame: Up to 14 weeks post-transplant (99 days)
Percentage of Participants With CMV End-organ Disease up to Week 24 Post-Transplant
Time frame: Up to 24 weeks post-transplant (approximately 6 months)
Percentage of Participants With All-Cause Mortality up to Week 14 Post-Transplant
Time frame: Up to 14 weeks post-transplant (99 days)
Percentage of Participants With All-cause Mortality up to Week 24 Post-Transplant
Time frame: Up to 24 weeks post-transplant (approximately 6 months)

Results and safety

Results posted to the registry on 25 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Letermovir	120	107

Primary outcome: Percentage of Participants With Clinically Significant Cytomegalovirus (CMV) Infection up to Week 24 Post-Transplant

Time frame: Up to Week 24 post-transplant (approximately 6 months). Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	Letermovir n = 98
Value	32 (23.5 to 42.9)

Population analysed: All allocated participants who received at least 1 dose of study treatment and have no detectable CMV viral deoxyribonucleic acid (DNA) when study intervention is initiated. Per protocol, participants who prematurely discontinued or had a missing outcome at the 24-week visit window were considered treatment failure (i.e. Non-completers equal failure \[NC=F\] approach was used).

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Letermovir	70 of 120 (58.3%)	118 of 120 (98.3%)	8 of 120

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Merck Clinical Trials InformationLink provided by the sponsor.
Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Related trials for Cytomegalovirus Infection

RecruitingObservational study
A Study of LIVTENCITY (Maribavir) in Adults With Cytomegalovirus (CMV) Infection After Transplantation in South Korea
Cytomegalovirus (CMV)
RecruitingObservational study
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
EBV, HSV
RecruitingPhase 1
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
Viral Infection
RecruitingPhase 2
CMV CTLs in Neonates With CMV Infection
Congenital Cytomegaloviral (CMV) Disease
RecruitingPhase 2
CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

21 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Letermovir in people with Cytomegalovirus Infection, run by Merck Sharp & Dohme LLC at 21 sites in China.

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 12 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 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in China. 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 25 Mar 2025). 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 Clinically Significant Cytomegalovirus (CMV) Infection up to Week 24 Post-Transplant (time frame: Up to Week 24 post-transplant (approximately 6 months)). 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 NCT05763823.

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 25 Mar 2025.