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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 to 365 days post intervention

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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

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I have received a heart or lung transplant.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

CMV viral load

Proportion of days during which appropriately renally-dosed prophylaxis

Secondary outcome measures

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%

Neutrophil count decreased

14%

Diarrhoea

14%

Hyperlipidaemia

Nausea

Incisional hernia

Leukopenia

Anaemia

Urinary tract infection

Insomnia

Haematuria

Herpes zoster

Pneumocystis jirovecii pneumonia

Tonsillitis

Complications of transplanted kidney

Adenoviral haemorrhagic cystitis

Constipation

Lymphocele

100%

80%

60%

40%

20%

Study treatment Arm

Letermovir

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,006 Previous Clinical Trials

42,882,972 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,892 Previous Clinical Trials

5,061,062 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Letermovir been granted regulatory clearance by the FDA?

"Our team at Power rates the safety of Letermovir as a 2. This is because Phase 2 trials have some clinical data to support its security, but none that indicate efficacy."

Answered by AI

Are additional participants currently being sought out for this clinical trial?

"This research study, which was initially posted on January 1st 2024 and most recently updated on September 27th 2023 is not currently recruiting. Nevertheless, there are 58 other studies that are open to candidates at this moment in time."

Answered by AI

What are the primary objectives of this clinical trial?

"This trial will measure the efficacy of prophylaxis over a 6-month period. Primarily, it aims to determine the proportion of days when renally dosed prophylaxis is appropriately administered. Secondary goals include assessing the rate of CMV resistance (determined by genomics sequencing), neutropenia (ANC less than 1500/microlitre) and severe thrombocytopenia (platelet count below 50,000/microlitre)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Open Label Trial of Oral Letermovir for CMV Prophylaxis in Thoracic Transplant Recipients

2024. "Open Label Trial of Oral Letermovir for CMV Prophylaxis in Thoracic Transplant Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06066957.

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