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Virus Therapy

Letermovir Prophylaxis for Cytomegalovirus Infection in Heart Transplant Recipients

Q: Is this an unprecedented research endeavor?

<p>To date, Merck Sharp &#x26; Dohme LLC has conducted 7 exploratory studies concerning this treatment. The initial trial was performed in 2019 and included 86 patients across 34 cities over 11 nations; Phase 2 drug approval followed shortly after its completion. Subsequent trials have been held since then.</p>

Phase 4

Waitlist Available

Research Sponsored by Tufts Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Heart transplant recipients who are not CMV donor negative and CMV recipient negative (CMV -/-)

Adults between 18-70 will be eligible for participation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial will compare the rates of CMV infection and disease in 30 heart transplant patients who will be given letermovir as prophylaxis to a retrospective cohort of 374 heart transplant patients. The tolerability of letermovir will also be assessed.

Who is the study for?

This trial is for adults aged 18-70 who have recently received a heart transplant and are at risk for cytomegalovirus, but not HIV positive or on dialysis. They mustn't be allergic to letermovir, participating in other clinical trials with investigational drugs, or planning to donate eggs/sperm within 90 days after the study.Check my eligibility

What is being tested?

The trial tests Letermovir as a preventive measure against CMV infection in heart transplant recipients. It compares outcomes of a new group of 30 patients with those from a past group of 374 patients, focusing on rates of neutropenia and drug tolerability.See study design

What are the potential side effects?

While specific side effects aren't listed here, typically antiviral medications like Letermovir could cause symptoms such as headache, nausea, vomiting, diarrhea; potential blood issues like neutropenia; and possibly allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I had a heart transplant and either I or my donor was not CMV negative.

Select...

I am between 18 and 70 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of patients with neutropenia

Secondary outcome measures

Measure of CMV specific T cell immunity in letermovir recipients compared to controls

Rate of CMV infection in letermovir recipients

Rate of opportunistic infections in letermovir arm compared to historic controls

+2 more

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

Hypertension

Acute kidney injury

Oropharyngeal pain

Insomnia

Erythema

Hyperkalaemia

Febrile neutropenia

Asthenia

Hyperglycaemia

Constipation

Arthralgia

Dizziness

Tremor

Dry skin

Pruritus

Alanine aminotransferase increased

Epistaxis

Thrombocytopenia

Dyspepsia

Stomatitis

Bacteraemia

Aspartate aminotransferase increased

Acute myeloid leukaemia recurrent

Anaemia

Dry eye

Abdominal pain upper

Dry mouth

Hypokalaemia

Hypomagnesaemia

Hyponatraemia

Back pain

Myalgia

Anxiety

Nasopharyngitis

Dysuria

Neutropenia

Chest pain

Pain in extremity

Dysgeusia

Hypotension

Pneumonia

Rhinorrhoea

Viraemia

Muscle spasms

Gastrooesophageal reflux disease

Acute lymphocytic leukaemia recurrent

Respiratory failure

Sepsis

Acute myeloid leukaemia

Hepatic function abnormal

Pneumonia bacterial

Staphylococcal bacteraemia

Viral haemorrhagic cystitis

Multiple organ dysfunction syndrome

Gastroenteritis

Gastrointestinal haemorrhage

Urinary tract infection

Sinusitis

Squamous cell carcinoma

Pneumothorax

Venoocclusive liver disease

Plasma cell myeloma recurrent

Herpes zoster

Pleural effusion

Pancytopenia

Bronchopulmonary aspergillosis

Cellulitis

Clostridium difficile colitis

Transplant failure

Myelodysplastic syndrome

Epstein-Barr virus infection

Gastroenteritis viral

Rhinovirus infection

Septic shock

Neurotoxicity

Acute lymphocytic leukaemia

Mantle cell lymphoma

Sciatica

Syncope

Cystitis haemorrhagic

Acute respiratory distress syndrome

Venoocclusive disease

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Letermovir

Trial Design

1Treatment groups

Experimental Treatment

Group I: single armExperimental Treatment1 Intervention

Letermovir 480 mg daily for cmv prophylaxis

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Letermovir

2019

Completed Phase 3

~1410

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Tufts Medical CenterLead Sponsor

253 Previous Clinical Trials

253,367 Total Patients Enrolled

2 Trials studying Infections

149 Patients Enrolled for Infections

Merck Sharp & Dohme LLCIndustry Sponsor

3,886 Previous Clinical Trials

5,054,522 Total Patients Enrolled

176 Trials studying Infections

586,680 Patients Enrolled for Infections

Media Library

Letermovir (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04904614 — Phase 4

Infections Research Study Groups: single arm

Infections Clinical Trial 2023: Letermovir Highlights & Side Effects. Trial Name: NCT04904614 — Phase 4

Letermovir (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04904614 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this an unprecedented research endeavor?

"To date, Merck Sharp & Dohme LLC has conducted 7 exploratory studies concerning this treatment. The initial trial was performed in 2019 and included 86 patients across 34 cities over 11 nations; Phase 2 drug approval followed shortly after its completion. Subsequent trials have been held since then."

Answered by AI

Who might be most suited to participate in this medical trial?

"For this research, 35 people between 18-70 years old who have neutropenia must be enrolled. Additionally, prospective participants should not be a heart transplant recipient with CMV serostatus of both donor and recipient negative (CMV -/-), or currently taking part in another clinical trial."

Answered by AI

What is the approximate size of the cohort involved in this clinical experiment?

"Yes, according to clinicaltrials.gov this trial is currently open for recruitment and was first announced on October 1st 2021. As of November 15th 2022 the study has yet to close off enrollment with 35 participants needed across two medical sites."

Answered by AI

Has this therapeutic protocol been accorded the endorsement of the Food & Drug Administration?

"With Phase 4 data available, our team at Power has reasonably concluded that this treatment is safe and assigned it a score of 3."

Answered by AI

Is this research open to senior citizens aged 75 and above?

"This medical study is seeking individuals aged between 18 years and 70 years."

Answered by AI

What prior research has been conducted concerning this therapeutic approach?

"Currently, there are seven active trials investigating this specific treatment. None of these live clinical experiments have reached Phase 3 yet. Despite the majority of studies being located in Columbus, Ohio, 67 sites worldwide are collecting patient data on this promising therapy."

Answered by AI

Are there any current openings in this clinical trial?

"Affirmative, according to clinicaltrials.gov's information this trial is presently recruiting patients. It was launched on October 1st 2021 and has been modified most recently on November 15th 2022. This research requires 35 willing participants between two sites."

Answered by AI

Recent research and studies

Clinical Infectious DiseasesJournal

Epidemiology of Infections After Solid‐organ Transplantation

Snydman, David R.. 2001. “Epidemiology of Infections After Solid‐organ Transplantation”. Clinical Infectious Diseases. Oxford University Press (OUP). doi:10.1086/320897.

Clinical Infectious DiseasesJournal

Definitions of Cytomegalovirus Infection and Disease in Transplant Patients for Use in Clinical Trials: Table 1.

Ljungman, Per, Michael Boeckh, Hans H. Hirsch, Filip Josephson, Jens Lundgren, Garrett Nichols, Andreas Pikis, Raymund R. Razonable, Veronica Miller, and Paul D. Griffiths. 2016. “Definitions of Cytomegalovirus Infection and Disease in Transplant Patients for Use in Clinical Trials: Table 1.”. Edited by David R. Snydman. Clinical Infectious Diseases. Oxford University Press (OUP). doi:10.1093/cid/ciw668.

Archives of Internal MedicineJournal

Influence of Blood Culture Results on Antibiotic Choice in the Treatment of Bacteremia

Arbo, Manuel D. J.. 1994. “Influence of Blood Culture Results on Antibiotic Choice in the Treatment of Bacteremia”. Archives of Internal Medicine. American Medical Association (AMA). doi:10.1001/archinte.1994.00420230024004.

The American Journal of MedicineJournal