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Virus Therapy

Letermovir for CMV Prevention After Lung Transplant

Phase 2
Recruiting
Led By Fernanda Silveira
Research Sponsored by Fernanda P Silveira, MD, MS
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to travel to UPMC for routine post-transplant visits for a minimum of 15 months after transplantation
Listed for lung transplantation (single or double) due to a diagnosis of IPF or receipt of a lung transplant (single or double) for IPF in the 72 hours prior to enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-12 months
Awards & highlights

Study Summary

This trial will test if letermovir can prevent CMV infection and disease in adult lung transplant recipients with idiopathic pulmonary fibrosis.

Who is the study for?
This trial is for adults over 18 with idiopathic pulmonary fibrosis who've had or will have a lung transplant and are CMV seropositive, or receive an organ from a CMV positive donor. They must be able to visit UPMC post-transplant for at least 15 months, provide consent, use contraception during the study and not have HIV/HCV, severe liver issues, need conflicting meds, or be pregnant.Check my eligibility
What is being tested?
The study tests Letermovir's effectiveness in preventing Cytomegalovirus infection after lung transplantation compared to historical data. It's open-label (participants know what treatment they're getting) and involves patients who meet specific CMV criteria.See study design
What are the potential side effects?
Letermovir may cause side effects like diarrhea, vomiting, swelling in limbs, headache, fatigue and could potentially affect kidney function. Valganciclovir can lead to similar digestive issues as well as potential blood cell count changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can travel to UPMC for follow-up visits for at least 15 months after my transplant.
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I am listed for or have had a lung transplant for IPF within the last 72 hours.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cytomegalovirus Infections
Cytomegalovirus Infections
Secondary outcome measures
Discontinuation events
Occurrence of leukopenia or neutropenia while on prophylaxis

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%
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%
Multiple organ dysfunction syndrome
1%
Hepatic function abnormal
1%
Pneumonia bacterial
1%
Staphylococcal bacteraemia
1%
Viral haemorrhagic cystitis
1%
Gastroenteritis
1%
Gastrointestinal haemorrhage
1%
Sinusitis
1%
Pneumothorax
1%
Urinary tract infection
1%
Squamous cell carcinoma
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

2Treatment groups
Experimental Treatment
Active Control
Group I: LetermovirExperimental Treatment1 Intervention
Participants who are CMV seropositive (CMV R+) will receive letermovir prophylaxis for 6 months, and participants who are CMV donor seropositive/recipient seronegative (CMV D+/R-) will receive letermovir prophylaxis for 12 months. Letermovir will be administered at a dose of 480 mg IV or oral once daily. IV administration will occur only for those patients unable to swallow tablets. If letermovir is co-administered with cyclosporine A, the dosage of letermovir will be decreased to 240 mg once daily.
Group II: ValganciclovirActive Control1 Intervention
Historical controls will be lung transplant recipients for idiopathic pulmonary fibrosis from 2010-2019 who are CMV R+ or CMV D+/R-. CMV prophylaxis in the historical controls was with valganciclovir for 6 months for CMV R+ and for 12 months for CMV D+/R-.
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?

Merck Sharp & Dohme LLCIndustry Sponsor
3,906 Previous Clinical Trials
5,064,788 Total Patients Enrolled
Fernanda P Silveira, MD, MSLead Sponsor
Fernanda SilveiraPrincipal InvestigatorUniversity of Pittsburgh

Media Library

Letermovir (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05041426 — Phase 2
Cytomegalovirus Research Study Groups: Valganciclovir, Letermovir
Cytomegalovirus Clinical Trial 2023: Letermovir Highlights & Side Effects. Trial Name: NCT05041426 — Phase 2
Letermovir (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05041426 — Phase 2
~9 spots leftby Jul 2025
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