CompletedNCT02137772Updated Sep 11, 2019Results posted

Letermovir (MK-8228) Versus Placebo in the Prevention of Clinically-Significant Cytomegalovirus (CMV) Infection in Adult, CMV-Seropositive Allogeneic Hematopoietic Stem Cell Transplant Recipients (MK-8228-001)

A Phase 3 interventional study of Letermovir and Placebo in Prevention of CMV Infection or Disease, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-11.

Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Prevention

Phase: Phase 3
Study type: Interventional
Enrollment: 570
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The study evaluated the efficacy and safety of letermovir (MK-8228) for the prevention of clinically-significant CMV infection in adult, CMV-seropositive recipients of allogeneic hematopoietic stem cell transplant (HSCT). The hypothesis being tested was that MK-8228 is superior to placebo in the prevention of clinically-significant CMV infection through Week 24 post-transplant.

Conditions studied

Prevention of CMV Infection or Disease

Browse trials for

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 570 is above the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Has documented seropositivity for CMV within 1 year before hematopoietic stem cell transplant (HSCT)
Receiving first allogeneic HSCT (bone marrow, peripheral blood stem cell, or cord blood transplant)
Female or male participant who is not of reproductive potential, or, if of reproductive potential, agrees to true abstinence or to use (or have their partner use) 2 acceptable methods of birth control from the time of consent through 90 days after the last dose of study drug
Able to read, understand, and complete questionnaires and diaries

Exclusion criteria

Exclusion Criteria:

Received a previous allogeneic HSCT (previous autologous HSCT is acceptable)
History of CMV end-organ disease within 6 months before randomization
Has evidence of CMV viremia (if tested) at any time from either signing of the Informed Consent Form or the HSCT procedure, whichever is earlier, until the time of randomization.
Received the following within 7 days before screening or plans to receive during the study: ganciclovir, valganciclovir, foscarnet, acyclovir, valacyclovir, or famciclovir
Received the following within 30 days before screening or plan to receive during the study: cidofovir, CMV hyper-immune globulin, any investigational CMV antiviral agent or biological therapy
Has suspected or known hypersensitivity to ingredients of MK-8228 (letermovir) formulations
Has severe hepatic insufficiency within 5 days before randomization
Has end-stage renal impairment
Has an uncontrolled infection on the day of randomization
Requires mechanical ventilation or is hemodynamically unstable at the time of randomization
Has documented positive results for human immunodeficiency virus (HIV) antibody, hepatitis C virus (HCV) antibody with detectable HCV ribonucleic acid, or hepatitis B surface antigen (HBsAg) within 90 days before randomization
Has active solid tumor malignancies with the exception of localized basal cell or squamous cell skin cancer or the condition under treatment (for example, lymphoma)
Is pregnant or expecting to conceive, is breastfeeding, or plans to breastfeed from the time of consent through 90 days after the last dose of study drug
Is expecting to donate eggs or sperm from the time of consent through 90 days after the last dose of study drug
Has participated in a study with an unapproved investigational compound (monoclonal antibodies are excepted) or device within 28 days of the first dose of study drug
Has previously participated in a MK-8228 (letermovir) study
Has, is, or is planning (during the study) to participate in any study involving administration of a CMV vaccine or another CMV investigational agent
Is a user of recreational or illicit drugs or has a recent history (\<=1 year) of drug or alcohol abuse or dependence

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 570 participants (actual)

Study arms

Experimental
Letermovir
Letermovir oral or intravenous (IV) formulation was administered once daily for up to 14 weeks, beginning up to Day 28 days post-transplant. The dose was 240 mg once daily for participants receiving concomitant cyclosporin A and 480 mg once daily for participants not receiving cyclosporin A. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
Drug: Letermovir
Placebo comparator
Placebo
Placebo oral or IV formulation was administered once daily for up to 14 weeks, beginning up to Day 28 post-transplant. The number of placebo tablets was to mimic that for letermovir administration according to the concomitant cyclosporin A status. Intravenous infusion was administered only to participants who are unable to swallow tablets or who have a condition that may interfere with absorption of the tablets.
Drug: Placebo

Interventions

DrugLetermovir
Letermovir 240 mg / 480 mg tablets, or 240 mg / 480 mg intravenous solution in 250 mL to be infused over 60 minutes.
Also known as: MK-8228
DrugPlacebo
Placebo tablets, or intravenous solution in 250 mL to be infused over 60 minutes.

What researchers measure

Primary outcomes

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

Secondary outcomes

Time to Onset of Clinically-significant CMV Infection (Kaplan-Meier Estimate of Percentage of Participants With a Qualifying Event at Week 24 Post-transplant)
Clinically-significant CMV infection was defined as either one of the following: 1) onset of CMV end-organ disease, or 2) initiation of anti-CMV pre-emptive therapy based on documented CMV viremia and the clinical condition of the participant. Time to onset of clinically-significant CMV infection was defined from the day of transplantation to the day the participant developed clinically-significant CMV infection, and was analyzed by the Kaplan-Meier method. Participants were censored at the last assessment for participants who discontinued or did not develop clinically-significant CMV infection.
Time frame: Up to Week 24 post-transplant
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) onset of CMV end-organ disease, or 2) initiation of anti-CMV pre-emptive therapy based on documented CMV viremia and the clinical condition of the participant. The percentage of participants with clinically-significant CMV infection was assessed.
Time frame: Up to Week 14 post-transplant
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 was included in this analysis. The percentage of participants with CMV end-organ disease was assessed.
Time frame: Up to Week 24 post-transplant
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 was included in this analysis. The percentage of participants with CMV end-organ disease was assessed.
Time frame: Up to Week 14 post-transplant
Percentage of Participants With Pre-emptive Therapy for CMV Viremia up to Week 14 Post-transplant
Initiation of anti-CMV pre-emptive therapy was based on documented CMV viremia and the clinical condition of the participant. The percentage of participants with initiation of anti-CMV pre-emptive anti-CMV therapy was assessed.
Time frame: Up to Week 14 post-transplant
Percentage of Participants With Pre-emptive Therapy for CMV Viremia up to Week 24 Post-transplant
Initiation of anti-CMV pre-emptive therapy was based on documented CMV viremia and the clinical condition of the participant. The percentage of participants with initiation of anti-CMV pre-emptive anti-CMV therapy was assessed.
Time frame: Up to Week 24 post-transplant
Time to Initiation of Pre-emptive Therapy for CMV Viremia (Kaplan-Meier Estimate of Percentage of Participants With a Qualifying Event at Week 24 Post-transplant)
The need for anti-CMV pre-emptive therapy was based on documented CMV viremia and the clinical condition of the participant. The outcome was calculated from the day of transplantation to the start of anti-CMV pre-emptive therapy, and was analyzed by the Kaplan-Meier method. Participants were censored at the last assessment for participants who discontinued or did not initiate pre-emptive therapy.
Time frame: Up to Week 24 post-transplant

Other outcomes

Percentage of Participants With One or More Adverse Events up to Week 48 Post-transplant
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can 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, is also an adverse event.
Time frame: Up to Week 48 post-transplant
Percentage of Participants Discontinued From Study Medication Due to an Adverse Event
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can 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, is also an adverse event.
Time frame: Up to Week 14 post-transplant

Results

Posted Nov 17, 2017

Participant flow

A total of 738 participants were screened, 570 were randomized 2:1 letermovir:placebo, and 565 received at least one dose of study medication.

Participant flow — Overall Study
Milestone	Letermovir	Placebo
Started	376	194
Treated participants	373	192
Completed	244	119
Not completed	132	75
Withdrew: Adverse event	6	3
Withdrew: Death	71	44
Withdrew: Lost to follow-up	8	4
Withdrew: Physician decision	15	5
Withdrew: Withdrawal by subject	28	17
Withdrew: Non-compliance with study drug	1	0
Withdrew: Not treated	3	2

Outcome measures

PrimaryPercentage of Participants With Clinically-significant CMV Infection up to Week 24 Post-transplant

Time frame:: Up to Week 24 post-transplant
Reported as:: Number · Percentage of participants

Percentage of Participants With Clinically-significant CMV Infection up to Week 24 Post-transplant
Percentage of participants	Letermovir	Placebo
Percentage of Participants With Clinically-significant CMV Infection up to Week 24 Post-transplant	37.5	60.6

Statistical analysis

Letermovir vs Placebo · Mantel Haenszel · p = <0.0001 (A 1-sided p-value ≤0.0249 for the risk difference was used for declaring statistical significance) · Risk difference (rd): -23.5 · 95% CI -32.5 to -14.6The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)

SecondaryTime to Onset of Clinically-significant CMV Infection (Kaplan-Meier Estimate of Percentage of Participants With a Qualifying Event at Week 24 Post-transplant)

Clinically-significant CMV infection was defined as either one of the following: 1) onset of CMV end-organ disease, or 2) initiation of anti-CMV pre-emptive therapy based on documented CMV viremia and the clinical condition of the participant. Time to onset of clinically-significant CMV infection was defined from the day of transplantation to the day the participant developed clinically-significant CMV infection, and was analyzed by the Kaplan-Meier method. Participants were censored at the last assessment for participants who discontinued or did not develop clinically-significant CMV infection.

Time frame:: Up to Week 24 post-transplant
Reported as:: Number · Percentage of participants

Time to Onset of Clinically-significant CMV Infection (Kaplan-Meier Estimate of Percentage of Participants With a Qualifying Event at Week 24 Post-transplant)
Percentage of participants	Letermovir	Placebo
Time to Onset of Clinically-significant CMV Infection (Kaplan-Meier Estimate of Percentage of Participants With a Qualifying Event at Week 24 Post-transplant)	18.9 (14.4 to 23.5)	44.3 (36.4 to 52.1)

Statistical analysis

Letermovir vs Placebo · Log Rank · p = <0.0001 (Nominal 2-sided p-value)The log rank test was adjusted for sample size for each stratum (high or low risk for CMV reactivation)

SecondaryPercentage of Participants With Clinically-significant CMV Infection up to Week 14 Post-transplant

Time frame:: Up to Week 14 post-transplant
Reported as:: Number · Percentage of participants

Percentage of Participants With Clinically-significant CMV Infection up to Week 14 Post-transplant
Percentage of participants	Letermovir	Placebo
Percentage of Participants With Clinically-significant CMV Infection up to Week 14 Post-transplant	19.1	50.0

Statistical analysis

Letermovir vs Placebo · Mantel Haenszel · p = <0.0001 (Nominal 1-sided p-value) · Risk difference (rd): -31.3 · 95% CI -39.9 to -22.6The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)

SecondaryPercentage 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 was included in this analysis. The percentage of participants with CMV end-organ disease was assessed.

Time frame:: Up to Week 24 post-transplant
Reported as:: Number · Percentage of participants

Percentage of Participants With CMV End-organ Disease up to Week 24 Post-transplant
Percentage of participants	Letermovir	Placebo
Percentage of Participants With CMV End-organ Disease up to Week 24 Post-transplant	2.0	2.4

Statistical analysis

Letermovir vs Placebo · Mantel Haenszel · p = 0.4056 (Nominal 1-sided p-value) · Risk difference (rd): -0.4 · 95% CI -4.0 to 3.2The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)

SecondaryPercentage of Participants With CMV End-organ Disease up to Week 14 Post-transplant

Time frame:: Up to Week 14 post-transplant
Reported as:: Number · Percentage of participants

Percentage of Participants With CMV End-organ Disease up to Week 14 Post-transplant
Percentage of participants	Letermovir	Placebo
Percentage of Participants With CMV End-organ Disease up to Week 14 Post-transplant	0.4	1.4

Statistical analysis

Letermovir vs Placebo · Mantel Haenszel · p = 0.2258 (Nominal 1-sided p-value) · Risk difference (rd): -1.0 · 95% CI -3.5 to 1.5The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)

SecondaryPercentage of Participants With Pre-emptive Therapy for CMV Viremia up to Week 14 Post-transplant

Initiation of anti-CMV pre-emptive therapy was based on documented CMV viremia and the clinical condition of the participant. The percentage of participants with initiation of anti-CMV pre-emptive anti-CMV therapy was assessed.

Time frame:: Up to Week 14 post-transplant
Reported as:: Number · Percentage of participants

Percentage of Participants With Pre-emptive Therapy for CMV Viremia up to Week 14 Post-transplant
Percentage of participants	Letermovir	Placebo
Percentage of Participants With Pre-emptive Therapy for CMV Viremia up to Week 14 Post-transplant	18.8	49.4

Statistical analysis

Letermovir vs Placebo · Mantel Haenszel · p = <0.0001 (Nominal 1-sided p-value) · Risk difference (rd): -31.0 · 95% CI -39.6 to -22.4The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)

SecondaryPercentage of Participants With Pre-emptive Therapy for CMV Viremia up to Week 24 Post-transplant

Time frame:: Up to Week 24 post-transplant
Reported as:: Number · Percentage of participants

Percentage of Participants With Pre-emptive Therapy for CMV Viremia up to Week 24 Post-transplant
Percentage of participants	Letermovir	Placebo
Percentage of Participants With Pre-emptive Therapy for CMV Viremia up to Week 24 Post-transplant	36.6	59.4

Statistical analysis

Letermovir vs Placebo · Mantel Haenszel · p = <0.0001 (Nominal 1-sided p-value) · Risk difference (rd): -23.3 · 95% CI -32.3 to -14.3The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)

SecondaryTime to Initiation of Pre-emptive Therapy for CMV Viremia (Kaplan-Meier Estimate of Percentage of Participants With a Qualifying Event at Week 24 Post-transplant)

The need for anti-CMV pre-emptive therapy was based on documented CMV viremia and the clinical condition of the participant. The outcome was calculated from the day of transplantation to the start of anti-CMV pre-emptive therapy, and was analyzed by the Kaplan-Meier method. Participants were censored at the last assessment for participants who discontinued or did not initiate pre-emptive therapy.

Time frame:: Up to Week 24 post-transplant
Reported as:: Number · Percentage of participants

Time to Initiation of Pre-emptive Therapy for CMV Viremia (Kaplan-Meier Estimate of Percentage of Participants With a Qualifying Event at Week 24 Post-transplant)
Percentage of participants	Letermovir	Placebo
Time to Initiation of Pre-emptive Therapy for CMV Viremia (Kaplan-Meier Estimate of Percentage of Participants With a Qualifying Event at Week 24 Post-transplant)	17.2 (12.8 to 21.6)	42.4 (34.7 to 50.2)

Statistical analysis

Letermovir vs Placebo · Log Rank · p = <0.0001 (Nominal 2-sided p-value)The log rank test analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)

Other pre-specifiedPercentage of Participants With One or More Adverse Events up to Week 48 Post-transplant

An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can 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, is also an adverse event.

Time frame:: Up to Week 48 post-transplant
Reported as:: Number · Percentage of participants

Percentage of Participants With One or More Adverse Events up to Week 48 Post-transplant
Percentage of participants	Letermovir	Placebo
Percentage of Participants With One or More Adverse Events up to Week 48 Post-transplant	98.4	100.0

Other pre-specifiedPercentage of Participants Discontinued From Study Medication Due to an Adverse Event

Time frame:: Up to Week 14 post-transplant
Reported as:: Number · Percentage of participants

Percentage of Participants Discontinued From Study Medication Due to an Adverse Event
Percentage of participants	Letermovir	Placebo
Percentage of Participants Discontinued From Study Medication Due to an Adverse Event	19.6	51.6

Adverse events

Collected over Up to Week 48 post-transplant. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Letermovir	—	202/373 (54.2%)	360/373 (96.5%)
Placebo	—	115/192 (59.9%)	186/192 (96.9%)

Most frequent serious events

Showing 10 of 230

Most frequent serious events
Event	Letermovir	Placebo
Graft versus host diseaseImmune system disorders	45/373	29/192
Acute myeloid leukaemia recurrentNeoplasms benign, malignant and unspecified (incl cysts and polyps)	23/373	17/192
Cytomegalovirus infectionInfections and infestations	14/373	15/192
Acute kidney injuryRenal and urinary disorders	7/373	9/192
PneumoniaInfections and infestations	15/373	6/192
Septic shockInfections and infestations	5/373	7/192
PyrexiaGeneral disorders	10/373	4/192
DiarrhoeaGastrointestinal disorders	3/373	5/192
SepsisInfections and infestations	8/373	4/192
Multiple organ dysfunction syndromeGeneral disorders	2/373	4/192

Most frequent other events

Showing 10 of 59

Most frequent other events
Event	Letermovir	Placebo
Cytomegalovirus infectionInfections and infestations	55/373	77/192
Graft versus host diseaseImmune system disorders	147/373	74/192
DiarrhoeaGastrointestinal disorders	108/373	51/192
NauseaGastrointestinal disorders	106/373	53/192
RashSkin and subcutaneous tissue disorders	90/373	51/192
PyrexiaGeneral disorders	85/373	50/192
VomitingGastrointestinal disorders	79/373	35/192
CoughRespiratory, thoracic and mediastinal disorders	62/373	27/192
Oedema peripheralGeneral disorders	60/373	23/192
HeadacheNervous system disorders	58/373	24/192

Baseline characteristics

Randomized participants

Age, Continuous
Age, Continuous(Years)	Letermovir	Placebo	Total
Mean	50.8 ± 13.4	50.8 ± 14.8	50.8 ± 13.9

Sex: Female, Male
Sex: Female, Male(Participants)	Letermovir	Placebo	Total
Female	162	77	239
Male	214	117	331

Risk Stratum for CMV Reactivation
Risk Stratum for CMV Reactivation(Participants)	Letermovir	Placebo	Total
High risk	122	54	176
Low risk	254	140	394

Study locations

No study locations are listed for this record.

References and documents

Publications

Prohn M, Cho CR, Viberg A, Dykstra K, Davis C, Sabato P, Stone J, Badshah C, Murata Y, Leavitt R, Fancourt C, Macha S. Exposure-Response Analyses of Letermovir Following Oral and Intravenous Administration in Allogeneic Hematopoietic Cell Transplantation Recipients. Clin Pharmacol Ther. 2022 Feb;111(2):485-495. doi: 10.1002/cpt.2456. Epub 2021 Nov 29. PubMed 34674258 ↗
Prohn M, Viberg A, Zhang D, Dykstra K, Davis C, Macha S, Sabato P, de Alwis D, Iwamoto M, Fancourt C, Cho CR. Population pharmacokinetics of letermovir following oral and intravenous administration in healthy participants and allogeneic hematopoietic cell transplantation recipients. CPT Pharmacometrics Syst Pharmacol. 2021 Mar;10(3):255-267. doi: 10.1002/psp4.12593. Epub 2021 Mar 12. PubMed 33440077 ↗
Ljungman P, Schmitt M, Marty FM, Maertens J, Chemaly RF, Kartsonis NA, Butterton JR, Wan H, Teal VL, Sarratt K, Murata Y, Leavitt RY, Badshah C. A Mortality Analysis of Letermovir Prophylaxis for Cytomegalovirus (CMV) in CMV-seropositive Recipients of Allogeneic Hematopoietic Cell Transplantation. Clin Infect Dis. 2020 Apr 10;70(8):1525-1533. doi: 10.1093/cid/ciz490. PubMed 31179485 ↗
Marty FM, Ljungman P, Chemaly RF, Maertens J, Dadwal SS, Duarte RF, Haider S, Ullmann AJ, Katayama Y, Brown J, Mullane KM, Boeckh M, Blumberg EA, Einsele H, Snydman DR, Kanda Y, DiNubile MJ, Teal VL, Wan H, Murata Y, Kartsonis NA, Leavitt RY, Badshah C. Letermovir Prophylaxis for Cytomegalovirus in Hematopoietic-Cell Transplantation. N Engl J Med. 2017 Dec 21;377(25):2433-2444. doi: 10.1056/NEJMoa1706640. Epub 2017 Dec 6. PubMed 29211658 ↗

Individual participant data

Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02137772
Lead sponsor: Merck Sharp & Dohme LLC
Responsible party: Sponsor
First posted: May 14, 2014
Start date: Jun 6, 2014
Primary completion: Aug 8, 2016
Completion: Nov 21, 2016
Results posted: Nov 17, 2017
Last update: Sep 11, 2019

Study contacts

Medical Director

study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Infections→

Other studies from this sponsor

Merck Sharp & Dohme LLC

Start the discussion

Letermovir (MK-8228) Versus Placebo in the Prevention of Clinically-Significant Cytomegalovirus (CMV) Infection in Adult, CMV-Seropositive Allogeneic Hematopoietic Stem Cell Transplant Recipients (MK-8228-001)

Study summary

Conditions studied

Browse trials for

In context

Infections

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Other outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Individual participant data

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria