Lung Transplant Clinical Trial
Official title:
An Open-label Pilot Protocol to Evaluate the Efficacy of Letermovir for the Prevention of Human Cytomegalovirus (CMV) Infection and Disease in Adult Lung Transplant Recipients With Idiopathic Pulmonary Fibrosis
This is an interventional, open-label, single center, pilot study with historical controls to test the efficacy of letermovir (LET) for the prevention of CMV infection and disease in adult lung transplant recipients (LTRs) with idiopathic pulmonary fibrosis (IPF).
Status | Recruiting |
Enrollment | 30 |
Est. completion date | July 1, 2025 |
Est. primary completion date | July 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - Age =18 years on day of signing informed consent - Listed for lung transplantation (single or double) due to a diagnosis of IPF or receipt of a lung transplant (single or double) for IPF in the 72 hours prior to enrollment - Have a documented positive serostatus for CMV (CMV IgG seropositive, R+) - Have a documented negative serostatus for CMV (CMV IgG seronegative, R-) and anticipate receiving or having received a lung allograft from a CMV IgG positive donor, D+). Only participants who are R+ or who are CMV D+/R- will receive intervention. Participants who are CMV D-/R- will be considered screen failures - Able to travel to UPMC for routine post-transplant visits for a minimum of 15 months after transplantation - Able to provide informed consent - Be willing to use a contraceptive method while receiving LET and for at least 90 days following last dose of LET Exclusion Criteria: - Receipt of a previous solid organ transplant or hematopoietic stem cell transplant - Multi-organ transplant recipient, i.e., heart-lung or lung-liver - HIV seropositive - HCV antibody or HCV RNA positive - Donor HCV NAT positive - Anticipated need for use of ganciclovir, valganciclovir, foscarnet, or cidofovir at the time of transplant - Known or suspected hypersensitivity to LET or acyclovir - CrCl < 10 ml/min or dialysis on day of transplant - Child-Pugh Class C severe hepatic insufficiency - Pregnancy or expected to conceive while on LET and through at least 90 days following cessation of LET |
Country | Name | City | State |
---|---|---|---|
United States | UPMC | Pittsburgh | Pennsylvania |
United States | UPMC | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Fernanda P Silveira, MD, MS | Merck Sharp & Dohme LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence of CMV infection or disease during prophylaxis | Proportion of lung transplant recipients with idiopathic pulmonary fibrosis with CMV infection or disease during letermovir prophylaxis. This will be compared to the proportion of CMV infection or disease in historical lung transplant recipients with idiopathic pulmonary fibrosis who received valganciclovir prophylaxis | 6-12 months post-transplant | |
Primary | Occurrence of CMV infection or disease in the 3 months following completion of prophylaxis | Proportion of lung transplant recipients with idiopathic pulmonary fibrosis with CMV infection or disease in the 3 months following completion of prophylaxis with letermovir. This will be compared to the proportion of CMV infection or disease in the 3 months following in historical lung transplant recipients with idiopathic pulmonary fibrosis who received valganciclovir prophylaxis. | 12 weeks after completion of letermovir | |
Secondary | Discontinuation events | Discontinuation of letermovir will be compared to discontinuation of valganciclovir in historical controls | 6-12 months | |
Secondary | Occurrence of leukopenia or neutropenia while on prophylaxis | Proportion of participants who develop any of the following while receiving letermovir: total WBC count = 3,500 cells/mL or absolute neutrophil count = 1,000 cells/mL. This will be compared to the rate of total WBC count = 3,500 cells/mL or absolute neutrophil count = 1,000 cells/mL in historical controls while receiving valganciclovir prophylaxis. | 6-12 months |
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