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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT06066957
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cytomegalovirus Infections
  • Transplant-Related Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Letermovir 480 MG [Prevymis] — DRUG
    Letermovir for CMV prophylaxis in thoracic organ transplant recipients. Letermovir will be administered by oral administration, as per study protocol. The intended duration of therapy will be up to 365 days, depending on organ transplanted and donor and recipient CMV status. However, treatment may discontinued as discussed in Section 7. Letermovir is dosed at 480mg daily for patients with CrCl \>10. Dose adjustment, as per package insert, is recommended in setting of co-administration of cyclosporine, with dose reduction of letermovir to 240mg daily. Missed doses of letermovir will not be made up.

Study Details

Open label study to determine tolerability and efficacy of letermovir for CMV prophylaxis in heart and lung transplant recipients. The study hypotheses are: 1. Letermovir prophylaxis will be associated with similar rates of CMV infection as valganciclovir among heart and lung transplant recipients 2. Letermovir will be better tolerated than valganciclovir for CMV prophylaxis in heart and lung transplant recipients, with a higher proportion of days of completed therapy with correct dosing during the planned prophylaxis period 3. Letermovir will have a lower rate of neutropenia than valganciclovir when used for CMV prophylaxis in heart and lung transplant recipients 4. Incorrect renal dosing will occur less frequently with letermovir than with valganciclovir when used for CMV prophylaxis in heart and lung transplant recipients

Key Dates

Start date
Apr 4, 2024
Status verified
Jun 2026
Primary completion
Aug 15, 2026
Completion
Aug 15, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Letermovir
    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).

Primary Outcome Measure

CMV viral load [ Time Frame: Prophylaxis period plus 180 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Penn Medicine at the University of PennsylvaniaPhiladelphiaPennsylvania19104
Kathryn Whitaker, MD
[email protected]
267-581-2135
Kathryn Whitaker, MD (PRINCIPAL_INVESTIGATOR)
Emily A Blumberg, MD (PRINCIPAL_INVESTIGATOR)
Emily Clausen, MD (SUB_INVESTIGATOR)
Juan Ortega-Legaspi, MD (SUB_INVESTIGATOR)

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By research site
Penn Medicine at the University of Pennsylvania· Philadelphia, PA

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