A Phase 3 interventional study of Letermovir and Valganciclovir in CMV Disease, sponsored by Merck Sharp & Dohme LLC. Completed at 94 sites in 16 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-28.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 3, Interventional, and Prevention
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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.
Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 131 are open to participants now.
Of its 503 completed or terminated interventional studies of FDA-regulated products, 371 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LET 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
Drug: Letermovir · Drug: Acyclovir (ACV) · Drug: Placebo to VGCV
900 mg VGCV tablet orally, once daily; placebo to LET tablet orally once daily; and placebo to ACV orally every 12 hours for 28 weeks
Drug: Valganciclovir · Drug: Placebo to ACV · Drug: Placebo to LET
LET 480mg (or 240 mg when administered concomitantly with cyclosporin A) once daily for 28 weeks
900 mg VGCV tablet orally, once daily for 28 weeks
400 mg over-encapsulated ACV tablet orally, every 12 hours for 28 weeks
Over-encapsulated placebo tablet orally, every 12 hours for 28 weeks
Placebo to LET tablet orally, once daily for 28 weeks
Placebo to VGCV tablet orally, once daily for 28 weeks
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.
Time frame: Up to 52 weeks
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.
Time frame: Up to 28 weeks
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.
Time frame: Up to 52 weeks
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.
Time frame: Up to 52 weeks
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.
Time frame: Up to 52 weeks
Male/Female participants of at least 18 years of age with receipt of a kidney transplant were enrolled in this trial.
| Milestone | Letermovir | Valganciclovir |
|---|---|---|
| Started | 301 | 300 |
| Treated | 292 | 297 |
| Completed | 256 | 266 |
| Not completed | 45 | 34 |
| Withdrew: Death | 3 | 3 |
| Withdrew: Withdrawal by subject | 34 | 22 |
| Withdrew: Lost to follow-up | 1 | 2 |
| Withdrew: Physician decision | 3 | 3 |
| Withdrew: Other | 4 | 4 |
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.
| Percentage of Participants | Letermovir | Valganciclovir |
|---|---|---|
| Percentage of Participants With Adjudicated Cytomegalovirus (CMV) Disease Through 52 Weeks Post-transplant | 10.4 | 11.8 |
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.
| Percentage of Participants | Letermovir | Valganciclovir |
|---|---|---|
| Percentage of Participants With Adjudicated CMV Disease Through 28 Weeks Post-transplant | 0.0 | 1.7 |
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.
| Days | Letermovir | Valganciclovir |
|---|---|---|
| Time to Onset of Adjudicated CMV Disease Through 52 Weeks Post-transplant | NA (NA to NA) | NA (NA to NA) |
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.
| Percentage of Participants | Letermovir | Valganciclovir |
|---|---|---|
| Percentage of Participants With Any AE | 92.8 | 92.9 |
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.
| Percentage of Participants | Letermovir | Valganciclovir |
|---|---|---|
| Percentage of Participants With Any Drug-related Serious Adverse Event (SAE) | 1.4 | 5.1 |
Collected over Up to 52 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Letermovir | 5/301 (1.7%) | 118/292 (40.4%) | 239/292 (81.8%) |
| Valganciclovir | 3/300 (1%) | 129/297 (43.4%) | 243/297 (81.8%) |
| Event | Letermovir | Valganciclovir |
|---|---|---|
| PyrexiaGeneral disorders | 9/292 | 1/297 |
| LeukopeniaBlood and lymphatic system disorders | 2/292 | 9/297 |
| Transplant rejectionImmune system disorders | 6/292 | 9/297 |
| Acute kidney injuryRenal and urinary disorders | 8/292 | 9/297 |
| Urinary tract infectionInfections and infestations | 8/292 | 8/297 |
| LymphoceleVascular disorders | 8/292 | 5/297 |
| DiarrhoeaGastrointestinal disorders | 2/292 | 8/297 |
| Cytomegalovirus infectionInfections and infestations | 7/292 | 8/297 |
| Blood creatinine increasedInvestigations | 7/292 | 3/297 |
| Kidney transplant rejectionImmune system disorders | 5/292 | 3/297 |
| Event | Letermovir | Valganciclovir |
|---|---|---|
| LeukopeniaBlood and lymphatic system disorders | 35/292 | 105/297 |
| DiarrhoeaGastrointestinal disorders | 99/292 | 85/297 |
| TremorNervous system disorders | 53/292 | 52/297 |
| NeutropeniaBlood and lymphatic system disorders | 7/292 | 50/297 |
| Oedema peripheralGeneral disorders | 44/292 | 47/297 |
| Urinary tract infectionInfections and infestations | 41/292 | 45/297 |
| HypertensionVascular disorders | 38/292 | 43/297 |
| HypomagnesaemiaMetabolism and nutrition disorders | 41/292 | 40/297 |
| Blood creatinine increasedInvestigations | 26/292 | 39/297 |
| HyperkalaemiaMetabolism and nutrition disorders | 32/292 | 38/297 |
| Age, Continuous(Years) | Letermovir | Valganciclovir | Total |
|---|---|---|---|
| Mean | 49.6 ± 14.8 | 49.5 ± 15.1 | 49.6 ± 14.9 |
| Sex: Female, Male(Participants) | Letermovir | Valganciclovir | Total |
|---|---|---|---|
| Female | 84 | 90 | 174 |
| Male | 217 | 210 | 427 |
| Ethnicity (NIH/OMB)(Participants) | Letermovir | Valganciclovir | Total |
|---|---|---|---|
| Hispanic or Latino | 56 | 45 | 101 |
| Not Hispanic or Latino | 230 | 240 | 470 |
| Unknown or Not Reported | 15 | 15 | 30 |
| Race (NIH/OMB)(Participants) | Letermovir | Valganciclovir | Total |
|---|---|---|---|
| American Indian or Alaska Native | 3 | 4 | 7 |
| Asian | 5 | 10 | 15 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 22 | 33 | 55 |
| White | 259 | 246 | 505 |
| More than one race | 9 | 6 | 15 |
| Unknown or Not Reported | 3 | 1 | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · engagezone.msd.com
Ran from May 2018 to primary completion in Apr 2022, 47 months.
Results were first posted in Apr 2023, 1 year after primary completion.
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Studies of the drug tested here: Letermovir