Prospective study to evaluate the efficacy of letermovir prophylaxis for the prevention of CMV infection in lung transplant recipients compared to a retrospective cohort treated with standard valganciclovir prophylaxis for 12 months (LETERCOR Study).

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacion Para La Investigacion Biomedica De Cordoba

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Trial duration

18 Dec 2023 → ongoing

Decision date (initial)

2023-08-24

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

MERCK SHARP & DOHME DE ESPAÑA S.A

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

Evaluate the efficacy of letermovir prophylaxis for 12 months in lung transplant recipients (D+/R-) compared to a historical cohort of lung transplant recipients (D+/R-) who were prescribed with a 12-month prophylaxis with valganciclovir to prevent CMV disease.

Secondary objectives 3

1. Evaluation of changes in medication directly related to CMV antiviral toxicity during the 12 months after the start of treatment:
2. To evaluate the long-term efficacy of 12-month prophylaxis with letermovir in lung transplant recipients (D+/R-) (Long-term efficacy: incidence of asymptomatic replication or late CMV disease during the 6 months following prophylaxis discontinuation).
3. Investigate whether patients with seroconversion and positive CMV-specific cell-mediated immunity (QuantiFERON-CMV reactive) will have a lower incidence of asymptomatic replication or late CMV disease after discontinuation of CMV prophylaxis with letermovir.

Conditions and MedDRA coding

lung transplant patients (D+/R-)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 18 years and older
2. Lung transplant patients (D+/R-) pre-transplant
3. Have an undetectable PCR-CMV within 96 hours prior to the start of letermovir prophylaxis (prospective cohort)
4. Patients who have given their written informed consent (prospective cohort)
5. Patients prescribed (intention to treat) with valganciclovir prophylaxis for 12 months (retrospective cohort)
6. Patients transplanted between 18/05/2020 and 18/11/2022 (retrospective cohort)

Exclusion criteria 5

1. HIV-infected patients
2. Multivisceral transplant patients
3. Patients who cannot comply with the study protocol (prospective cohort)
4. Receiving an antiviral prophylaxis other than ganciclovir or valganciclovir prior to letermovir prophylaxis (prospective cohort)
5. Patients with simultaneous renal and hepatic insufficiency (prospective cohort)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence of CMV disease/replication for 12 months after initiation of prophylaxis.

Secondary endpoints 9

1. Administered doses of Letermovir or Valganciclovir
2. CMV Medications: Any non-antiviral therapy received as SoC for CMV management (eg immunoglobulins)
3. Changes in the patient's medication directly related to the toxicity of CMV antivirals
4. Incidence of leukopenia. (Leukopenia will be considered if the total leukocyte number is less than 3,000/mL and neutropenia if the total neutrophil number is less than 1,000/mL)
5. Hospital readmission associated with CMV complications
6. Incidence of opportunistic viral, bacterial, or fungal infections during the study follow-up period
7. Incidence of renal toxicity directly related to CMV antivirals
8. Rate of patients achieving functional CMV-specific cell-mediated immunity (CMI-CMV) levels after receiving letermovir prophylaxis during the 6 months following discontinuation.
9. Rate of CMV-seropositive patients after receiving letermovir prophylaxis during the 6 months following discontinuation

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacion Para La Investigacion Biomedica De Cordoba

Sponsor organisation

Fundacion Para La Investigacion Biomedica De Cordoba

Address

Avenida Menendez Pidal S/n

City

Cordoba

Postcode

14004

Country

Spain

Scientific contact point

Organisation

Fundacion Para La Investigacion Biomedica De Cordoba

Contact name

Jose Carlos Garrido Gracia

Public contact point

Organisation

Fundacion Para La Investigacion Biomedica De Cordoba

Contact name

Jose Carlos Garrido Gracia

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications