To navigate the following site navigation expect to utilize the tab key to move through items sequentially. The spacebar or enter keys can be utilized to interact with items that open sub-navigation.
When autocomplete results are available use up and down arrows to review and enter to select.
Letermovir for CMV Prevention After Lung Transplantation
Study Purpose
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).
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
No
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Interventional
Eligible Ages
18 Years and Over
Gender
All
More Inclusion & Exclusion Criteria
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
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Phase 2
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
Fernanda P Silveira, MD, MS
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study.
Fernanda Silveira
Principal Investigator Affiliation
University of Pittsburgh
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
Other, Industry
Overall Status
Recruiting
Countries
United States
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied.
Lung Transplant, CMV
Additional Details
Approximately 30 patients with IPF listed for lung transplantation will be enrolled and 15
are expected to undergo lung transplantation during the study period and receive the
intervention. Patients who are CMV seropositive will receive letermovir for 6 months,
patients who are CMV seronegative and receive lungs from a CMV seropositive donor (CMV D+/R-)
will receive letermovir for 12 months. All patients will be followed for 12 weeks after
completion of letermovir for the occurrence of CMV infection or disease after prophylaxis.
Historical controls will be LTRs for IPF from 2010-2019 who are CMV R+ or CMV D+/R- (donor
positive/recipient negative). CMV prophylaxis in the historical controls was with
valganciclovir for 6 months for CMV R+ and for 12 months for CMV D+/R-. Patients will be
matched for CMV serostatus, induction immunosuppression, age, and telomere length.
Arms & Interventions
Arms
Experimental: Letermovir
Participants who are CMV seropositive (CMV R+) will receive letermovir prophylaxis for 6 months, and participants who are CMV donor seropositive/recipient seronegative (CMV D+/R-) will receive letermovir prophylaxis for 12 months. Letermovir will be administered at a dose of 480 mg IV or oral once daily. IV administration will occur only for those patients unable to swallow tablets. If letermovir is co-administered with cyclosporine A, the dosage of letermovir will be decreased to 240 mg once daily.
Active Comparator: Valganciclovir
Historical controls will be lung transplant recipients for idiopathic pulmonary fibrosis from 2010-2019 who are CMV R+ or CMV D+/R-. CMV prophylaxis in the historical controls was with valganciclovir for 6 months for CMV R+ and for 12 months for CMV D+/R-.
Interventions
Drug: - Letermovir
Participants who are CMV R+ will receive LET prophylaxis for 6 months, and participants who are CMV D+/R- will receive LET prophylaxis for 12 months. The duration of prophylaxis is per current standard of care. LET will be administered at a dose of 480 mg IV or oral once daily. IV administration will occur only for those patients unable to swallow tablets. If LET is co-administered with cyclosporin A (CsA), the dosage of LET should be decreased to 240 mg once daily. All patients will be followed for 12 weeks after completion of LET for the occurrence of CMV infection or disease after prophylaxis. Participants on this protocol will receive acyclovir 400 mg orally BID for the duration of LET therapy for herpes simplex virus and varicella zoster virus prophylaxis.
Drug: - Valganciclovir
Historical controls will have received CMV prophylaxis with valganciclovir for 6 months for CMV R+ and for 12 months for CMV D+/R-.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.