Study Summary
This trial will compare the rates of CMV infection and disease in 30 heart transplant patients who will be given letermovir as prophylaxis to a retrospective cohort of 374 heart transplant patients. The tolerability of letermovir will also be assessed.
- Heart Transplant Infection
- Cytomegalovirus (CMV)
- Neutropenia
- Antiviral Toxicity
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 5 Secondary · Reporting Duration: 1 year
Trial Safety
Safety Progress
Trial Design
0 Treatment Group
35 Total Participants · 0 Treatment Group
Primary Treatment: Treatment · No Placebo Group · Phase 4
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 70 · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Snydman, David R.. 2001. “Epidemiology of Infections After Solid‐organ Transplantation”. Clinical Infectious Diseases. Oxford University Press (OUP). doi:10.1086/320897.
- Ljungman, Per, Michael Boeckh, Hans H. Hirsch, Filip Josephson, Jens Lundgren, Garrett Nichols, Andreas Pikis, Raymund R. Razonable, Veronica Miller, and Paul D. Griffiths. 2016. “Definitions of Cytomegalovirus Infection and Disease in Transplant Patients for Use in Clinical Trials: Table 1.”. Edited by David R. Snydman. Clinical Infectious Diseases. Oxford University Press (OUP). doi:10.1093/cid/ciw668.
- Arbo, Manuel D. J.. 1994. “Influence of Blood Culture Results on Antibiotic Choice in the Treatment of Bacteremia”. Archives of Internal Medicine. American Medical Association (AMA). doi:10.1001/archinte.1994.00420230024004.
- George, Marie J., David R. Snydman, Barbara G. Werner, John Griffith, Matthew E. Falagas, Nancy N. Dougherty, and Robert H. Rubin. 1997. “The Independent Role of Cytomegalovirus as a Risk Factor for Invasive Fungal Disease in Orthotopic Liver Transplant Recipients”. The American Journal of Medicine. Elsevier BV. doi:10.1016/s0002-9343(97)80021-6.
- Goldner, Thomas, Guy Hewlett, Nicole Ettischer, Helga Ruebsamen-Schaeff, Holger Zimmermann, and Peter Lischka. 2011. “The Novel Anticytomegalovirus Compound AIC246 (letermovir) Inhibits Human Cytomegalovirus Replication Through a Specific Antiviral Mechanism That Involves the Viral Terminase”. Journal of Virology. American Society for Microbiology. doi:10.1128/jvi.05265-11.
- Lischka, Peter, Guy Hewlett, Tobias Wunberg, Judith Baumeister, Daniela Paulsen, Thomas Goldner, Helga Ruebsamen-Schaeff, and Holger Zimmermann. 2010. “in vitro and in Vivo Activities of the Novel Anticytomegalovirus Compound AIC246”. Antimicrobial Agents and Chemotherapy. American Society for Microbiology. doi:10.1128/aac.01596-09.
- Marschall, Manfred, Thomas Stamminger, Andreas Urban, Steffen Wildum, Helga Ruebsamen-Schaeff, Holger Zimmermann, and Peter Lischka. 2012. “in Vitro Evaluation of the Activities of the Novel Anticytomegalovirus Compound AIC246 (letermovir) Against Herpesviruses and Other Human Pathogenic Viruses”. Antimicrobial Agents and Chemotherapy. American Society for Microbiology. doi:10.1128/aac.05908-11.
- Gardiner, Bradley J, Natalie E Nierenberg, Jennifer K Chow, Robin Ruthazer, David M Kent, and David R Snydman. 2018. “Absolute Lymphocyte Count: A Predictor of Recurrent Cytomegalovirus Disease in Solid Organ Transplant Recipients”. Clinical Infectious Diseases. Oxford University Press (OUP). doi:10.1093/cid/ciy295.
- Kaul, D. R., S. Stoelben, E. Cober, T. Ojo, E. Sandusky, P. Lischka, H. Zimmermann, and H. Rubsamen-Schaeff. 2011. “First Report of Successful Treatment of Multidrug-resistant Cytomegalovirus Disease with the Novel Anti-cmv Compound AIC246”. American Journal of Transplantation. Wiley. doi:10.1111/j.1600-6143.2011.03530.x.
- Kotton, Camille N., Deepali Kumar, Angela M. Caliendo, Shirish Huprikar, Sunwen Chou, Lara Danziger-Isakov, and Atul Humar. 2018. “The Third International Consensus Guidelines on the Management of Cytomegalovirus in Solid-organ Transplantation”. Transplantation. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/tp.0000000000002191.
- Marty, Francisco M., Per Ljungman, Roy F. Chemaly, Johan Maertens, Sanjeet S. Dadwal, Rafael F. Duarte, Shariq Haider, et al.. 2017. “Letermovir Prophylaxis for Cytomegalovirus in Hematopoietic-cell Transplantation”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1706640.
- Giulieri, Stefano, and Oriol Manuel. 2011. “Quantiferon®-cmv Assay for the Assessment of Cytomegalovirus Cell-mediated Immunity”. Expert Review of Molecular Diagnostics. Informa UK Limited. doi:10.1586/erm.10.109.
- Marty, Francisco M., Per Ljungman, Roy F. Chemaly, Johan Maertens, Sanjeet S. Dadwal, Rafael F. Duarte, Shariq Haider, et al.. 2017. “Letermovir Prophylaxis for Cytomegalovirus in Hematopoietic-cell Transplantation”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1706640.
- Ljungman P, Boeckh M, Hirsch HH, Josephson F, Lundgren J, Nichols G, Pikis A, Razonable RR, Miller V, Griffiths PD; Disease Definitions Working Group of the Cytomegalovirus Drug Development Forum. Definitions of Cytomegalovirus Infection and Disease in Transplant Patients for Use in Clinical Trials. Clin Infect Dis. 2017 Jan 1;64(1):87-91. doi: 10.1093/cid/ciw668. Epub 2016 Sep 28.
- Kotton CN, Kumar D, Caliendo AM, Huprikar S, Chou S, Danziger-Isakov L, Humar A; The Transplantation Society International CMV Consensus Group. The Third International Consensus Guidelines on the Management of Cytomegalovirus in Solid-organ Transplantation. Transplantation. 2018 Jun;102(6):900-931. doi: 10.1097/TP.0000000000002191.
- Arbo MD, Snydman DR. Influence of blood culture results on antibiotic choice in the treatment of bacteremia. Arch Intern Med. 1994 Dec 12-26;154(23):2641-5. doi: 10.1001/archinte.1994.00420230024004.
- George MJ, Snydman DR, Werner BG, Griffith J, Falagas ME, Dougherty NN, Rubin RH. The independent role of cytomegalovirus as a risk factor for invasive fungal disease in orthotopic liver transplant recipients. Boston Center for Liver Transplantation CMVIG-Study Group. Cytogam, MedImmune, Inc. Gaithersburg, Maryland. Am J Med. 1997 Aug;103(2):106-13. doi: 10.1016/s0002-9343(97)80021-6.
- Giulieri S, Manuel O. QuantiFERON(R)-CMV assay for the assessment of cytomegalovirus cell-mediated immunity. Expert Rev Mol Diagn. 2011 Jan;11(1):17-25. doi: 10.1586/erm.10.109.
- Snydman DR. Epidemiology of infections after solid-organ transplantation. Clin Infect Dis. 2001 Jul 1;33 Suppl 1:S5-8. doi: 10.1086/320897.
- 2021. "Letermovir Use in Heart Transplant Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04904614.
Frequently Asked Questions
Is this an unprecedented research endeavor?
"To date, Merck Sharp & Dohme LLC has conducted 7 exploratory studies concerning this treatment. The initial trial was performed in 2019 and included 86 patients across 34 cities over 11 nations; Phase 2 drug approval followed shortly after its completion. Subsequent trials have been held since then." - Anonymous Online Contributor
Who might be most suited to participate in this medical trial?
"For this research, 35 people between 18-70 years old who have neutropenia must be enrolled. Additionally, prospective participants should not be a heart transplant recipient with CMV serostatus of both donor and recipient negative (CMV -/-), or currently taking part in another clinical trial." - Anonymous Online Contributor
What is the approximate size of the cohort involved in this clinical experiment?
"Yes, according to clinicaltrials.gov this trial is currently open for recruitment and was first announced on October 1st 2021. As of November 15th 2022 the study has yet to close off enrollment with 35 participants needed across two medical sites." - Anonymous Online Contributor
Has this therapeutic protocol been accorded the endorsement of the Food & Drug Administration?
"With Phase 4 data available, our team at Power has reasonably concluded that this treatment is safe and assigned it a score of 3." - Anonymous Online Contributor
Is this research open to senior citizens aged 75 and above?
"This medical study is seeking individuals aged between 18 years and 70 years." - Anonymous Online Contributor
What prior research has been conducted concerning this therapeutic approach?
"Currently, there are seven active trials investigating this specific treatment. None of these live clinical experiments have reached Phase 3 yet. Despite the majority of studies being located in Columbus, Ohio, 67 sites worldwide are collecting patient data on this promising therapy." - Anonymous Online Contributor
Are there any current openings in this clinical trial?
"Affirmative, according to clinicaltrials.gov's information this trial is presently recruiting patients. It was launched on October 1st 2021 and has been modified most recently on November 15th 2022. This research requires 35 willing participants between two sites." - Anonymous Online Contributor