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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
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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
Rate of Relapse after prophylaxis
Secondary study objectives
Adverse events associated with taking letermovir
Neutropenia
Opportunistic infection
+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
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%
Gastrooesophageal reflux disease
2%
Acute lymphocytic leukaemia recurrent
2%
Respiratory failure
2%
Sepsis
2%
Acute myeloid leukaemia
1%
Staphylococcal bacteraemia
1%
Hepatic function abnormal
1%
Multiple organ dysfunction syndrome
1%
Pneumonia bacterial
1%
Gastrointestinal haemorrhage
1%
Viral haemorrhagic cystitis
1%
Sinusitis
1%
Urinary tract infection
1%
Pneumothorax
1%
Venoocclusive liver disease
1%
Squamous cell carcinoma
1%
Plasma cell myeloma recurrent
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

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.

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
263 Previous Clinical Trials
264,436 Total Patients Enrolled
Jennifer K Chow, MD, MSPrincipal InvestigatorTufts Medical Center
David R Snydman, MDPrincipal InvestigatorTufts Medical Center

Media Library

single arm Clinical Trial Eligibility Overview. Trial Name: NCT05626530 — Phase 4
Cytomegalovirus Infection Research Study Groups: single arm
Cytomegalovirus Infection Clinical Trial 2023: single arm Highlights & Side Effects. Trial Name: NCT05626530 — Phase 4
single arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT05626530 — Phase 4
~10 spots leftby Dec 2025
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