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Virus Therapy

Letermovir for CMV in Transplant Recipients

Phase 3
Recruiting
Led By Margaret Jorgenson, PharmD, BCTXP
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must have high-risk CMV serostatus (D+/R-) at the time of transplant
Patient must have undergone kidney or simultaneous kidney/pancreas transplant
Must not have
Patient develops ganciclovir-resistant CMV infection
Patient has contraindication to letermovir or its excipients
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

"This trial aims to see how well letermovir can prevent CMV infection from coming back in adult kidney or kidney/pancreas transplant patients at UW Health. Patients will be involved in the

Who is the study for?
This trial is for adult kidney or kidney/pancreas transplant recipients at UW Health who are at risk of cytomegalovirus (CMV) infection. The study lasts about 6 months, and participants must meet specific health criteria to join.
What is being tested?
The effectiveness of Letermovir (Prevymis) in preventing the recurrence of CMV infections post-transplant is being tested. Participants will receive this medication over a period to assess its protective benefits.
What are the potential side effects?
Possible side effects of Letermovir may include headaches, nausea, vomiting, diarrhea, abdominal pain, fatigue, coughing and potential drug interactions with other medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am at high risk for CMV infection after my transplant.
Select...
I have had a kidney or kidney/pancreas transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a CMV infection that did not respond to ganciclovir treatment.
Select...
I cannot take letermovir or its ingredients due to adverse reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Duration of valganciclovir (VGC) Treatment
Number of distinct episodes of any cytomegalovirus replication greater than 1000 IU/mL
Secondary study objectives
Number of Participants with Positive Result for T-Cell Immunity Panel (TCIP) Testing

Side effects data

From 2016 Phase 3 trial • 570 Patients • NCT02137772
39%
Graft versus host disease
29%
Diarrhoea
28%
Nausea
24%
Rash
23%
Pyrexia
21%
Vomiting
17%
Cough
16%
Oedema peripheral
16%
Headache
15%
Cytomegalovirus infection
15%
Fatigue
13%
Abdominal pain
12%
Mucosal inflammation
12%
Decreased appetite
10%
Blood creatinine increased
10%
Dyspnoea
9%
Hypertension
9%
Acute kidney injury
9%
Oropharyngeal pain
9%
Insomnia
9%
Erythema
8%
Febrile neutropenia
8%
Hyperkalaemia
8%
Asthenia
8%
Hyperglycaemia
8%
Constipation
8%
Arthralgia
8%
Dizziness
8%
Tremor
8%
Dry skin
8%
Pruritus
7%
Alanine aminotransferase increased
7%
Epistaxis
7%
Thrombocytopenia
6%
Dyspepsia
6%
Stomatitis
6%
Bacteraemia
6%
Aspartate aminotransferase increased
6%
Acute myeloid leukaemia recurrent
6%
Anaemia
6%
Dry eye
6%
Abdominal pain upper
6%
Dry mouth
6%
Hypokalaemia
6%
Hypomagnesaemia
6%
Hyponatraemia
6%
Back pain
6%
Myalgia
6%
Anxiety
5%
Nasopharyngitis
5%
Dysuria
5%
Neutropenia
5%
Chest pain
5%
Pain in extremity
5%
Dysgeusia
4%
Hypotension
4%
Pneumonia
4%
Rhinorrhoea
3%
Viraemia
3%
Muscle spasms
2%
Acute lymphocytic leukaemia recurrent
2%
Gastrooesophageal reflux disease
2%
Respiratory failure
2%
Sepsis
2%
Acute myeloid leukaemia
1%
Hepatic function abnormal
1%
Sinusitis
1%
Gastrointestinal haemorrhage
1%
Viral haemorrhagic cystitis
1%
Staphylococcal bacteraemia
1%
Urinary tract infection
1%
Pneumothorax
1%
Venoocclusive liver disease
1%
Multiple organ dysfunction syndrome
1%
Pneumonia bacterial
1%
Plasma cell myeloma recurrent
1%
Squamous cell carcinoma
1%
Gastroenteritis
1%
Herpes zoster
1%
Pleural effusion
1%
Pancytopenia
1%
Bronchopulmonary aspergillosis
1%
Cellulitis
1%
Clostridium difficile colitis
1%
Transplant failure
1%
Myelodysplastic syndrome
1%
Epstein-Barr virus infection
1%
Gastroenteritis viral
1%
Rhinovirus infection
1%
Septic shock
1%
Neurotoxicity
1%
Acute lymphocytic leukaemia
1%
Mantle cell lymphoma
1%
Sciatica
1%
Syncope
1%
Cystitis haemorrhagic
1%
Acute respiratory distress syndrome
1%
Venoocclusive disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Letermovir

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Letermovir for CMV in Transplant PatientsExperimental Treatment1 Intervention
Enrolled participants will be converted from treatment with ganciclovir derivatives to letermovir
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Letermovir
2019
Completed Phase 3
~1530

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,231 Previous Clinical Trials
3,199,795 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,015 Previous Clinical Trials
5,186,243 Total Patients Enrolled
Margaret Jorgenson, PharmD, BCTXPPrincipal InvestigatorUniversity of Wisconsin, Madison
~60 spots leftby Sep 2026
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