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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

Must not have

HCV antibody or HCV RNA positive

CrCl < 10 ml/min or dialysis on day of transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have tested positive for hepatitis C.

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My kidney function is very low or I am on dialysis.

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I might need antiviral drugs at the time of my transplant.

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I am HIV positive.

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I have received multiple organ transplants, such as heart and lung or lung and liver.

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My liver is severely damaged.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cytomegalovirus Infections

Secondary study objectives

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

Hypertension

Acute kidney injury

Oropharyngeal pain

Insomnia

Erythema

Febrile neutropenia

Hyperkalaemia

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

Acute lymphocytic leukaemia recurrent

Gastrooesophageal reflux disease

Respiratory failure

Sepsis

Acute myeloid leukaemia

Hepatic function abnormal

Sinusitis

Gastrointestinal haemorrhage

Viral haemorrhagic cystitis

Staphylococcal bacteraemia

Urinary tract infection

Pneumothorax

Venoocclusive liver disease

Multiple organ dysfunction syndrome

Pneumonia bacterial

Plasma cell myeloma recurrent

Squamous cell carcinoma

Gastroenteritis

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 9Eligibility criteria met