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New treatment option for Cytomegalovirus Prophylaxis
Official title A Clinical Study of Letermovir (MK-8228) in Children and Adolescents Who Receive a Kidney Transplant (KT) (MK-8228-077)
ClinicalTrials.gov ID: NCT07199465
What this study is testing
What is Letermovir?
Letermovir is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for cytomegalovirus prophylaxis.
Also referred to as MK-8228, AIC246.
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
- Researchers are looking for a way to prevent cytomegalovirus (CMV) in children and adolescents who receive a kidney transplant (KT) and weigh less than 40 kilograms (88.2 pounds). The goals of the study are to: Learn what happens to letermovir in the body over time Learn about the safety of letermovir and if participants tolerate it
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 17
You may be able to join if
- The main include but are not limited to the following:
- Is a recipient of a primary or secondary allograft kidney
- Is at least 4 weeks posttransplant and not more than 52 weeks posttransplant at the time of enrollment (Day 1) and is being managed per local...
- Has stable kidney function posttransplant
- Has undetectable CMV deoxyribonucleic acid (DNA) from a plasma or whole blood sample collected within 14 days prior to enrollment
You likely can't join if
- The main exclusion criteria include but are not limited to the following:
- Has CMV disease or suspected CMV disease between screening and enrollment
- Is on dialysis or plasmapheresis at the time of enrollment
- Has evidence of CMV viremia at any time from screening until the time of enrollment
- Has Child-Pugh B or C hepatic insufficiency within 14 days before enrollment
- Is a multi-organ transplant recipient (e.g., kidney-pancreas)
See the full eligibility criteria
- The main include but are not limited to the following:
- Is a recipient of a primary or secondary allograft kidney
- Is at least 4 weeks posttransplant and not more than 52 weeks posttransplant at the time of enrollment (Day 1) and is being managed per local standard of care
- Has stable kidney function posttransplant
- Has undetectable CMV deoxyribonucleic acid (DNA) from a plasma or whole blood sample collected within 14 days prior to enrollment
- Must be able to take (as assessed by the investigator) letermovir tablets or oral pellets by mouth, or via gastrostomy or nasogastric tube (oral pellets only)
- Does not have a condition that may interfere with the absorption of oral medication (e.g., vomiting, diarrhea, or a malabsorptive condition) from the day of enrollment (Day 1) until the intensive pharmacokinetics (IPK)...
- Weighs ≥2.5 and \<40 kg at enrollment (Day 1)
- The main exclusion criteria include but are not limited to the following:
- Has CMV disease or suspected CMV disease between screening and enrollment
- Is on dialysis or plasmapheresis at the time of enrollment
- Has evidence of CMV viremia at any time from screening until the time of enrollment
- Has Child-Pugh B or C hepatic insufficiency within 14 days before enrollment
- Is a multi-organ transplant recipient (e.g., kidney-pancreas)
- Has any uncontrolled infection on the day of enrollment
- Requires mechanical ventilation, or is hemodynamically unstable, at the time of enrollment
- Has received or is receiving protocol-specified prohibited medications
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Miami, Florida, United States
- Chicago, Illinois, United States
- Ann Arbor, Michigan, United States
- Minneapolis, Minnesota, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- The Bronx, New York, United States
- Charlotte, North Carolina, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, 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, up to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Los Angeles, California, United States; Palo Alto, California, United States; Sacramento, California, United States; San Francisco, California, United States; Aurora, Colorado, United States and 12 more location(s). 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.