← Back to Search

Antiviral

Letermovir for CMV Prophylaxis in Transplant Patients

Phase 2

Recruiting

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A male or female subject who is of reproductive potential agrees to true abstinence or to use (or have their partner use) 1 acceptable method of birth control starting from the time of consent through 90 days after the last dose of study therapy. True abstinence is defined as abstinence in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., abstinence only on certain calendar days, abstinence only during ovulation period, use of symptothermal method, use of post-ovulation methods) and withdrawal are not acceptable methods of contraception. Acceptable methods of birth control are: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, and vasectomy OR use of appropriate double barrier contraception as per local regulations or guidelines. Hormonal contraceptives (e.g., birth control pills, transdermal patch, or injectables) are unacceptable methods of birth control for use in this study because it is not known whether these methods are affected by co-administration of letermovir.

Heart or Lung transplant recipient

Must not have

Child-Pugh Class C severe hepatic insufficiency at enrollment

Both moderate hepatic insufficiency AND moderate renal insufficiency. Note: Moderate hepatic insufficiency is defined as Child Pugh Class B; moderate renal insufficiency is defined as a creatinine clearance less than 50 mL/min, as calculated by the Cockcroft-Gault equation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 to 365 days post intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if letermovir is a better option than valganciclovir for CMV prophylaxis in heart and lung transplant recipients.

Who is the study for?

This trial is for heart or lung transplant recipients who are CMV seropositive, can start oral medication within 14 days post-transplant, and agree to use contraception. Excluded are those with prior transplants, treated CMV infections, severe organ dysfunction, certain drug sensitivities, uncontrolled infections, recent malignancies (except some skin cancers), pregnancy/breastfeeding intentions or participation in other investigational studies.

What is being tested?

The study tests the tolerability and effectiveness of Letermovir as a preventive treatment against CMV infection in transplant patients compared to historical data from Valganciclovir users. It aims to show that Letermovir has similar infection rates but fewer side effects like neutropenia and incorrect dosing issues.

What are the potential side effects?

Potential side effects of Letermovir may include digestive problems, headaches, coughing and fatigue. Less common but more serious risks could involve liver enzyme elevation or allergic reactions. The exact profile will be studied versus Valganciclovir's known side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I agree to use effective birth control or practice true abstinence during and 90 days after the study.

Select...

I have received a heart or lung transplant.

Exclusion Criteria

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

Select...

I have severe liver problems.

Select...

I have moderate liver and kidney problems.

Select...

I have taken or plan to take specific antiviral drugs for more than 14 days.

Select...

I have been treated for a CMV infection before.

Select...

I have never taken letermovir.

Select...

I haven't had cancer, except for skin cancer, in the last 5 years.

Select...

I cannot take pills by mouth 14 days after my transplant.

Select...

I have received transplants for two different organs.

Select...

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

Select...

I do not have any untreated infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 to 365 days post intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 to 365 days post intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 to 365 days post intervention for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

CMV viral load

Proportion of days during which appropriately renally-dosed prophylaxis

Secondary study objectives

Frequency of Acute cellular rejection

Number subjects with Incorrect renal dosing at any point during the planned prophylaxis period (measured as a binary variable, where the outcome is met if the recipient receives any days of incorrect dosing per their GFR).

Proportion of subjects who develop CMV resistance

+3 more

Side effects data

From 2022 Phase 3 trial • 22 Patients • NCT04129398

18%

Stomatitis

14%

Diarrhoea

14%

Hyperlipidaemia

14%

Neutrophil count decreased

Nausea

Insomnia

Anaemia

Leukopenia

Urinary tract infection

Haematuria

Incisional hernia

Tonsillitis

Complications of transplanted kidney

Constipation

Adenoviral haemorrhagic cystitis

Herpes zoster

Pneumocystis jirovecii pneumonia

Lymphocele

100%

80%

60%

40%

20%

Study treatment Arm

Letermovir

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: LetermovirExperimental Treatment1 Intervention

Will include those participants who receive letermovir for CMV prophylaxis as provided through the clinical trial. The "exposed" group will be ascertained prospectively over a one-year period (the "post-intervention" period).

0 / 12Eligibility criteria met