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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 belowSelect...
I can travel to UPMC for follow-up visits for at least 15 months after my transplant.
Select...
I am listed for or have had a lung transplant for IPF within the last 72 hours.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-12 months
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 • 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%
Hepatic function abnormal
1%
Pneumonia bacterial
1%
Staphylococcal bacteraemia
1%
Viral haemorrhagic cystitis
1%
Gastroenteritis
1%
Urinary tract infection
1%
Squamous cell carcinoma
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
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
~1410
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,060,641 Total Patients Enrolled
Fernanda P Silveira, MD, MSLead Sponsor
Fernanda SilveiraPrincipal InvestigatorUniversity of Pittsburgh
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have tested positive for hepatitis C.I can travel to UPMC for follow-up visits for at least 15 months after my transplant.My kidney function is very low or I am on dialysis.I might need antiviral drugs at the time of my transplant.I am listed for or have had a lung transplant for IPF within the last 72 hours.I am CMV negative and my lung donor was CMV positive, or I am CMV positive.I am HIV positive.I have received multiple organ transplants, such as heart and lung or lung and liver.My liver is severely damaged.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Valganciclovir
- Group 2: Letermovir
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Does the experiment include geriatric participants?
"This trial has set the age range of eligibility from 18 to 100 years old. For those under 18 and over 65, separate trials have been setup with a total number of 39 clinical studies in play."
Answered by AI
Has the Food and Drug Administration given its stamp of approval for Letermovir?
"There is some evidence suggesting the safety of Letermovir, and thus it was rated a 2 on our scale. This drug has yet to receive conclusive data confirming its efficacy."
Answered by AI
Might I be a suitable candidate for this clinical experiment?
"Those hoping to partake in this medical trial must have undergone a lung transplant, be within the 18-100 year old age range and meet other specified criteria. Currently, 30 individuals are sought after for the study."
Answered by AI
Is this experiment still taking in new participants?
"Affirmative. Clinicaltrials.gov reveals that the trial, which was published on December 6th 2021, is currently seeking volunteers. A total of 30 participants are required from a single location."
Answered by AI
In what medical conditions is Letermovir most regularly prescribed?
"Letermovir is an effective form of treatment for cytomegalovirus infections, allogeneic hematopoietic stem cell transplantation, and acquired immunodeficiency syndrome."
Answered by AI
What is the current enrollment capacity of this medical research?
"Affirmative. Clinicaltrials.gov records that this research project, which was originally advertised on December 6th 2021, is recruiting now and requires 30 individuals from 1 centre to join the trial."
Answered by AI
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