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Infections, CytomegalovirusPhase 2LETERCORNCT06057194

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

A Phase 2 study testing Letermovir 240 mg Oral Tablet in people with Infections, Cytomegalovirus, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Infections, Cytomegalovirus
What is being tested?
Letermovir 240 mg Oral Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteSpain
Study dates
Oct 2023to Apr 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.

Who cannot join

  • 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.
  • HIV-infected patients.
  • Patients with multivisceral transplant.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jose C Garrido Gracia, Ph.D contact

+34677906567

josecarlos.garrido@imibic.org

Spain1 site

  • Hospital Universitario Reina Sofia

    Córdoba, Córdoba, 14004

    Aurora Paez Vega, Ph.D, aumapave@hotmail.com

    Julián C De la Torre Cisneros, MD

Other trials in Spain

About this study

Official title: Prospective Study to Assess the Efficacy of Letermovir Prophylaxis in Preventing CMV Infection in Lung Transplant Recipients Compared to a Retrospective Cohort Treated With Standard Valganciclovir Prophylaxis for 12 Months (LETERCOR Study)

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."

Being tested
Letermovir 240 mg Oral Tablet
Keywords
Lung transplant, CMV prophylaxis, Cytomegalovirus
Medical subject headings
Cytomegalovirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Letermovir 240 mg Oral TabletDrug

    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.

Study groups in NCT06057194
Study groupRoleWhat they receive
Letermovir (prospective cohort)Experimental2 tablets of 240 milligrams (mg) Letermovir orally once daily. during 12 months
Receives: Drug: Letermovir 240 mg Oral Tablet
Valganciclovir (retrospective cohort)No interventionRetrospective cohort, of patients treated with Valganciclovir during 12 months

What is being measured

The primary outcome is the main question the study is designed to answer.

  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."

    Measured: During 12 months after initiation of prophylaxis

Secondary outcomes (15)

  1. Antiviral prophylaxis received:

    Doses administered of Letermovir or Valganciclovir

    Measured: During 12 months after initiation of prophylaxis

  2. 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)

    Drug Dose (mg/hour)

    Measured: During 12 months after initiation of prophylaxis

  3. 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)

    Drug Administration Route

    Measured: During 12 months after initiation of prophylaxis

  4. 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)

    Drug treatment duration (days)

    Measured: During 12 months after initiation of prophylaxis

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

    Drug Reason for Discontinuation

    Measured: During 12 months after initiation of prophylaxis

  6. Reduction of the antiviral dose related to CMV antiviral toxicity

    Number of events of reduction

    Measured: During 12 months after initiation of prophylaxis

  7. Substitution of letermovir by intravenous ganciclovir or foscarnet IV, related to CMV antiviral toxicity

    Number of substitutions

    Measured: During 12 months after initiation of prophylaxis

  8. Dose changes of immunosuppressive therapy related to CMV antiviral toxicity

    Number of changes

    Measured: During 12 months after initiation of prophylaxis

  9. Changes of immunosuppressive therapy related to CMV antiviral toxicity

    Number of changes

    Measured: During 12 months after initiation of prophylaxis

  10. Use of granulocyte colony-stimulating factors (G-CSF).

    Number of events (use)

    Measured: During 12 months after initiation of prophylaxis

  11. Incidence of leucopenia

    Incidence of leucopenia. (leucopenia will be considered if the total leukocyte count is less than 3,000/mL)

    Measured: During 12 months after initiation of prophylaxis

  12. Incidence of neutropenia

    Incidence of leucopenia. (neutropenia will be considered if the total neutrophil count is less than 1,000/mL)

    Measured: During 12 months after initiation of prophylaxis

  13. Hospital readmission associated with CMV complication

    Number of events

    Measured: During 12 months after initiation of prophylaxis

  14. Incidence of viral, bacterial, or opportunistic fungal infections during the study follow-up period.

    Number of events

    Measured: During 12 months after initiation of prophylaxis

  15. Incidence of renal toxicity directly related to CMV antivirals.

    Number of events

    Measured: During 12 months after initiation of prophylaxis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2023
  2. Study startOct 2023 (estimated)
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Clinical trial of a prospective cohort compared to a retrospective (historical control) cohort.
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06057194
Sponsor's protocol ID
FCO-LET-2022-01
Other IDs
2023-504384-16-00, 2023
Acronym
LETERCOR
Status last verified
Sep 2023
First submitted
15 Sep 2023
Last updated
28 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Letermovir 240 mg Oral Tablet in people with Infections, Cytomegalovirus, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jose C Garrido Gracia, Ph.D (+34677906567, josecarlos.garrido@imibic.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of CMV disease/replication (time frame: During 12 months after initiation of prophylaxis). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06057194.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.

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