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Letermovir for Solid Organ Transplant Infection
Phase 4
Recruiting
Led By Jennifer K Chow, MD, MS
Research Sponsored by Tufts Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial tests a drug to prevent CMV infection & disease in a solid organ transplant recipient after treatment.
Who is the study for?
This trial is for adults over 18 who've had a solid organ transplant (heart, kidney, or liver) and are recovering from treated CMV disease. They should need secondary prophylaxis against CMV and be able to follow up for 6 months. Excluded are those with very low kidney function, severe liver issues, recent malignancies other than certain skin cancers, pregnant or breastfeeding individuals, drug abusers within the last 6 months, or participants in conflicting trials.Check my eligibility
What is being tested?
The study tests Letermovir as a preventive treatment to stop Cytomegalovirus (CMV) from coming back in patients who have received an organ transplant and already been treated for CMV infection. It's an open-label trial where everyone knows they're getting Letermovir.See study design
What are the potential side effects?
Possible side effects of Letermovir include allergic reactions in those sensitive to it; however specific side effects aren't listed here. Patients will be monitored for any adverse reactions during the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of Relapse after prophylaxis
Secondary outcome measures
Adverse events associated with taking letermovir
Neutropenia
Opportunistic infection
+2 moreSide effects data
From 2016 Phase 3 trial • 570 Patients • NCT0213777239%
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%
Hyperkalaemia
8%
Febrile neutropenia
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%
Gastrooesophageal reflux disease
2%
Acute lymphocytic leukaemia recurrent
2%
Respiratory failure
2%
Sepsis
2%
Acute myeloid leukaemia
1%
Gastrointestinal haemorrhage
1%
Squamous cell carcinoma
1%
Hepatic function abnormal
1%
Pneumonia bacterial
1%
Staphylococcal bacteraemia
1%
Viral haemorrhagic cystitis
1%
Gastroenteritis
1%
Urinary tract infection
1%
Multiple organ dysfunction syndrome
1%
Sinusitis
1%
Pneumothorax
1%
Venoocclusive liver disease
1%
Plasma cell myeloma recurrent
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
Trial Design
1Treatment groups
Experimental Treatment
Group I: single armExperimental Treatment1 Intervention
This is an open label single arm study
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?
Tufts Medical CenterLead Sponsor
256 Previous Clinical Trials
255,722 Total Patients Enrolled
Jennifer K Chow, MD, MSPrincipal InvestigatorTufts Medical Center
David R Snydman, MDPrincipal InvestigatorTufts Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver is not working well (severe issues).I am on dialysis.I have moderate liver and kidney problems.I haven't had cancer, except for certain skin cancers or early-stage cervical cancer, in the last 5 years.I am an adult organ transplant recipient needing further treatment for CMV.I am allergic to letermovir or my CMV is resistant to it.My kidney function is very low.
Research Study Groups:
This trial has the following groups:- Group 1: single arm
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research protocol permitting geriatric patients to participate?
"The eligibility criterion of this study requires that participants must be over 18 yet under 75 years old."
Answered by AI
Has this treatment been certified by the Food and Drug Administration?
"As this treatment has reached the approval stage of clinical trials, it can be assumed to have a high safety rating of 3."
Answered by AI
How many participants are enrolled in this experiment?
"Affirmative, information on clinicaltrials.gov indicates that this experiment is still recruiting patients. It was initially published on February 2nd 2023 and has most recently been updated March 21st 2023. This trial requires 25 individuals to be enrolled from 1 site."
Answered by AI
Is participation in this research endeavor open to me?
"Those hoping to partake in this clinical trial must be afflicted with cytomegalovirus, and between the ages of 18-75. The maximum number of participants is 25."
Answered by AI
Are there any vacancies in this experiment that volunteers can join?
"Affirmative. Data hosted on clinicaltrials.gov attests to the fact that this trial, which was originally posted on February 2nd 2023, is actively accepting enrolment applications. Around 25 patients need to be registered from a single medical center."
Answered by AI
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