Efficacy of Letermovir in Preventing Cytomegalovirus (CMV) Infection in Lung Transplant Recipients vs. Valganciclovir.

NCT06057194 | Not Yet Recruiting Phase 2

• 2 other identifiers: FCO-LET-2022-012023-504384-16-00
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this quasi-experimental multicenter before-after cohort study, phase II study is to evaluate the efficacy of 12-month letermovir prophylaxis in lung transplant recipients (D+/R-) compared to a historical cohort of lung transplant recipients (D+/R-) who received 12 months of valganciclovir prophylaxis to prevent CMV disease."

Conditions

Infections, Cytomegalovirus

Keywords

Lung transplant; CMV prophylaxis; Cytomegalovirus

Outcome Measures

Primary Outcomes (1)

• Incidence of CMV disease/replication

  CMV replication: The term 'replication' can be used to indicate evidence of multiplication and is sometimes used interchangeably with CMV infection CMV disease: It is defined as symptomatic replication or invasive disease of organs or tissues that requires treatment at the investigator's discretion."

  During 12 months after initiation of prophylaxis

Secondary Outcomes (15)

• Antiviral prophylaxis received:

  During 12 months after initiation of prophylaxis

• Dose of non anti-viral CMV Medications: Any non-antiviral therapy received as standard of care (SoC) for the management of CMV (e.g., immunoglobulins)

  During 12 months after initiation of prophylaxis

• Administration route of non-antiviral CMV Medications: Any non-antiviral therapy received as standard of care (SoC) for the management of CMV (e.g., immunoglobulins)

  During 12 months after initiation of prophylaxis

• Duration of treatment of non-antiviral CMV Medications: Any non-antiviral therapy received as standard of care (SoC) for the management of CMV (e.g., immunoglobulins)

  During 12 months after initiation of prophylaxis

• Discontinuation of non-antiviral CMV Medications: Any non-antiviral therapy received as standard of care (SoC) for the management of CMV (e.g., immunoglobulins)

  During 12 months after initiation of prophylaxis

Study Arms (2)

Letermovir (prospective cohort)

EXPERIMENTAL

2 tablets of 240 milligrams (mg) Letermovir orally once daily. during 12 months

Drug: Letermovir 240 mg Oral Tablet

Valganciclovir (retrospective cohort)

NO INTERVENTION

Retrospective cohort, of patients treated with Valganciclovir during 12 months

Interventions

Letermovir 240 mg Oral Tablet DRUG

Treatment will commence as soon as subjects can receive oral medication, with a maximum timeframe of 28 days after transplantation. If patients cannot receive oral medication after transplantation, initial prophylaxis with ganciclovir per clinical practice will be allowed. Medication will be discontinued 12 months after treatment initiation.

Letermovir (prospective cohort)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults over 18 years old
• Lung transplant recipients (D+/R-) pre-transplant.
• Having an undetectable CMV polymerase chain reaction assay (PCR) within the 96 hours prior to the start of letermovir prophylaxis.
• Patients who have provided written informed consent.

You may not qualify if:

• HIV-infected patients.
• Patients with multivisceral transplant.
• Patients unable to comply with the follow-up protocol.
• Receiving a different antiviral prophylaxis other than ganciclovir prior to letermovir prophylaxis.
• Patients with concurrent renal and hepatic insufficiency.
• Adults over 18 years old. Lung transplant recipients (D+/R-) pre-transplant.
• Patients treated with Valganciclovir prophylaxis for 12 months.
• Patients transplanted within 2 years prior to the start of the study.
• Patients with a complete 13-month follow-up and comparable data to the prospective cohort to evaluate the study's primary variables.
• HIV-infected patients.
• Patients with multivisceral transplant.

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead
• MERCK SHARP & DOHME DE ESPAÑA S.A.: collaborator

Study Sites (1)

Hospital Universitario Reina Sofia

Córdoba, Córdoba, 14004, Spain

Location

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

letermovir; Tablets

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Julián C De la Torre Cisneros, MD

  Hospital Universitario Reina Sofia de Cordoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose C Garrido Gracia, Ph.D

CONTACT

+34677906567; josecarlos.garrido@imibic.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clinical trial of a prospective cohort compared to a retrospective (historical control) cohort.

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: September 28, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

ES (1)