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New treatment option for Cytomegalovirus Infections
Official title Open Label Trial of Oral Letermovir for CMV Prophylaxis in Thoracic Transplant Recipients
ClinicalTrials.gov ID: NCT06066957
What this study is testing
What is Letermovir 480 MG [Prevymis]?
Letermovir 480 MG [Prevymis] is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for cytomegalovirus infections.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Open label study to determine tolerability and efficacy of letermovir for CMV prophylaxis in heart and lung transplant recipients. The study hypotheses are: 1.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Age is \>=18 years on the day of transplantation.
- Heart or Lung transplant recipient.
- Donor and/or Recipient CMV seropositive (defined by positive IgG) within 1 year prior to transplantation.
- Able to start oral CMV prophylaxis within 14 days (heart graft recipients) or 28 days (lung graft recipients) of transplantation.
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Any prior solid organ transplant.
- Dual organ transplantation.
- Prior treated CMV infection.
- Unknown CMV serostatus of the donor or recipient.
- Suspected or known hypersensitivity to active or inactive ingredients of letermovir formulations and/or acyclovir formulations.
See the full eligibility criteria
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Age is \>=18 years on the day of transplantation.
- Heart or Lung transplant recipient.
- Donor and/or Recipient CMV seropositive (defined by positive IgG) within 1 year prior to transplantation.
- Able to start oral CMV prophylaxis within 14 days (heart graft recipients) or 28 days (lung graft recipients) of transplantation.
- Males at birth agree to use contraception during the treatment period, and for at least 90 days after the last dose of study treatment, and refrain from donating sperm during this period.
- Female at birth is not pregnant or breastfeeding. If of childbearing potential, agrees to follow the contraception guidance during the treatment period and for at least 90 days after the last dose of study treatment.
- A male or female subject who is of reproductive potential agrees to true abstinence or to use (or have their partner use) 1 acceptable method of birth control starting from the time of consent through 90 days after the...
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Any prior solid organ transplant.
- Dual organ transplantation.
- Prior treated CMV infection.
- Unknown CMV serostatus of the donor or recipient.
- Suspected or known hypersensitivity to active or inactive ingredients of letermovir formulations and/or acyclovir formulations.
- CrCl \<10 mL/minute, using Cockcroft-Gault equation, or renal replacement therapy at the time of enrollment.
- Child-Pugh Class C severe hepatic insufficiency at enrollment.
- Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 5 x the upper limit of normal (ULN) or serum total bilirubin \> 2.5 x ULN. Note: people who meet this exclusion criterion may, at the...
- Both moderate hepatic insufficiency AND moderate renal insufficiency. Note: Moderate hepatic insufficiency is defined as Child Pugh Class B; moderate renal insufficiency is defined as a creatinine clearance less than 50...
- Neutropenia, defined as absolute neutrophil count \<1,500/microliter, at the time of enrollment.
- Severe thrombocytopenia, defined as platelets \<50,000/microliter, at the time of enrollment.
- Any uncontrolled infection on the day of enrollment.
- Documented positive results for human immunodeficiency virus antibody (HIV-Ab) test at any time prior to enrollment, or hepatitis B surface antigen (HBsAg) within 90 days prior to enrollment.
- Documented positive result for hepatitis C virus antibody (HCV-Ab) and with detectable HCV ribonucleic acid (RNA) within 90 days prior to enrollment with need for treatment with direct acting antiviral other than the...
- Pregnant or expecting to conceive, is breastfeeding, or plans to breastfeed from the time of consent through at least 90 days following cessation of study therapy.
- Expecting to donate eggs or sperm starting from the time of consent through at least 90 days following cessation of study therapy.
- Received within 30 days prior to enrollment or plans to receive during the study any of the following anti-CMV IgG antibody treatment or anti-CMV drug therapy including the following: Cidofovir, CMV hyper-immune...
- Heart transplant recipients received \>14 days of IV ganciclovir or oral valganciclovir prior to initiation of study drug or plans to receive during the study any of the following anti-CMV drug therapy: ganciclovir...
- Currently participating or has participated in a study with an unapproved investigational compound within 28 days, or 5× half-life of the investigational compound whichever is longer, of initial dosing on this study.
- Previously participated in this study or any other study involving letermovir.
- Previously participated or is currently participating in any study involving administration of a CMV vaccine or another CMV investigational agent or is planning to participate in a study of a CMV vaccine or another CMV...
- For unexposed people, any letermovir exposure.
- Are unable to take medications orally by day 14 post heart transplant or by day 28 post lung transplant.
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.