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Tests treatment safety and results for Cytomegalovirus (CMV)
Official title A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Antiviral Activity of Maribavir for the Treatment of Cytomegalovirus (CMV) Infection in Children and Adolescents Who Have Received a Hematopoietic Stem Cell Transplant (HSCT) or a Solid Organ Transplant (SOT)
ClinicalTrials.gov ID: NCT05319353
What this study is testing
What is Maribavir?
Maribavir is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for cytomegalovirus (cmv).
Also referred to as TAK-620.
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
- The main aim of this study is to find out the safety, tolerability and pharmacokinetics (PK) of maribavir for the treatment of CMV infection in children and teenagers after HSCT or SOT and to identify the optimal dose of maribavir using a 200 milligrams (mg) tablet formulation or powder for oral suspension. The participants will be treated with maribavir for 8 weeks.
- Phase 3: a large, late-stage 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
- Parent/both parents or legally authorized representative (LAR) must provide signature of informed consent and there must be documentation of assent...
- Be a male or female child or adolescent \< 18 years of age at the time of consent. For participants in Cohort 3 only (0 to \<6 years) must have a...
- Be a recipient of an SOT or an HSCT that is functioning at the time of screening.
- Have a documented CMV infection which may be a first episode of post-transplant CMV viremia (primary or reactivation) or refractory to other anti-CMV...
- Have all the following results as part of screening laboratory assessments:
You likely can't join if
- Have CMV tissue invasive disease involving the central nervous system (CNS) or retina as assessed by the investigator at the time of screening.
- Have uncontrolled other type of infection as assessed by the investigator on the date of enrollment.
- Have a history of clinically relevant alcohol or drug abuse that may interfere with treatment compliance or assessments with the protocol as...
- Be receiving valganciclovir, ganciclovir, cidofovir, foscarnet, leflunomide, letermovir, or artesunate when study treatment is initiated, or...
- Have a known hypersensitivity to maribavir or to any excipients.
- Have severe vomiting, diarrhea, or other severe gastrointestinal (GI) illness within 24 hours prior to the first dose of study treatment or a GI...
See the full eligibility criteria
- Parent/both parents or legally authorized representative (LAR) must provide signature of informed consent and there must be documentation of assent by the participant, as age appropriate, before completing any...
- Be a male or female child or adolescent \< 18 years of age at the time of consent. For participants in Cohort 3 only (0 to \<6 years) must have a gestational age of at least 39 weeks and a minimum weight of 5 kg.
- Be a recipient of an SOT or an HSCT that is functioning at the time of screening.
- Have a documented CMV infection which may be a first episode of post-transplant CMV viremia (primary or reactivation) or refractory to other anti-CMV treatments, with a CMV DNA screening value of \>= 1365 International...
- Have all the following results as part of screening laboratory assessments:
- Absolute neutrophil count \>= 500 per cubic millimeter (/mm\^3) (0.5 × 10\^9 per liter [/L])
- Platelet count \>= 15,000/mm\^3 (15 × 10\^9/L)
- Hemoglobin \>= 8 grams per deciliter (g/dL) (\>=80 grams per liter [g/L]).
- Have an estimated glomerular filtration rate (creatinine-based Bedside Schwartz equation) \>= 30 milliliters per minute (mL/min) /1.73 meter square (m\^2).
- Be a female of nonchildbearing potential. If a female of childbearing potential, have a negative serum human chorionic gonadotropin (hCG) or beta-human chorionic gonadotropin (β-hCG) pregnancy test at screening. Males...
- Have life expectancy of \>= 8 weeks.
- Be willing and have an understanding and ability to fully comply with the study procedures and restrictions defined in the protocol. For younger children, the parent/both parents or LAR must meet this criterion.
- Participants must have a confirmed negative human immunodeficiency virus (HIV) test result within 3 months of first dose of study drug or, if unavailable, be tested by a local laboratory during the screening period.
- Have CMV tissue invasive disease involving the central nervous system (CNS) or retina as assessed by the investigator at the time of screening.
- Have uncontrolled other type of infection as assessed by the investigator on the date of enrollment.
- Have a history of clinically relevant alcohol or drug abuse that may interfere with treatment compliance or assessments with the protocol as determined by the investigator.
- Be receiving valganciclovir, ganciclovir, cidofovir, foscarnet, leflunomide, letermovir, or artesunate when study treatment is initiated, or anticipated to require one of these agents during the 8-week treatment period.
- Have a known hypersensitivity to maribavir or to any excipients.
- Have severe vomiting, diarrhea, or other severe gastrointestinal (GI) illness within 24 hours prior to the first dose of study treatment or a GI absorption abnormality that would preclude administration of oral...
- Require mechanical ventilation or vasopressors for hemodynamic support at baseline (Visit 2/Day 1/Week 0).
- Be pregnant (or expecting to conceive) or nursing.
- Have previously completed, discontinued, or have been withdrawn from this study.
- Have received any investigational agent or device within 30 days before initiation of study treatment (includes CMV specific T-cells) or plan to receive an investigational agent or device during the study. Previously...
- Have previously received maribavir or CMV vaccine at any time.
- Have any clinically significant medical or surgical condition that, in the investigator's opinion, could interfere with interpretation of study results, contraindicate the administration of the study treatment, or...
- Have severe liver disease (Child-Pugh score of \>= 10).
- Have serum aspartate aminotransferase greater than (\>) 5 times upper limit of normal (ULN) at screening, or serum alanine aminotransferase \> 5 times ULN at screening, or total bilirubin \>= 3.0 times ULN at screening...
- Have positive results for HIV.
- Have active malignancy with the exception of nonmelanoma skin cancer, as determined by the investigator. Participants who experience relapse or progression of their underlying malignancy (for which HSCT or SOT was...
- Be undergoing treatment for acute or chronic hepatitis B or hepatitis C.
- Requiring ongoing treatment with or an anticipated need for treatment with a strong cytochrome P450 3A (CYP3A) inducer.
- Have a low body weight where total blood volume (TBV) required during study participation will exceed 1 percent (%) TBV per study visit or 3% TBV over a 4-week period.
The study team makes the final eligibility decision.
Where it's taking place
- Wilmington, Delaware, United States
- St. Petersburg, Florida, United States
- Chicago, Illinois, United States
- Omaha, Nebraska, United States
- Cincinnati, Ohio, United States
- Fort Worth, Texas, United States
- Houston, Texas, United States
- Randwick, New South Wales, Australia
- Woollangabba, Queensland, Australia
- Parkville, Victoria, Australia
- Nedlands, Western Australia, Australia
- Brussels, Brussels Capital, Belgium
- Woluwe-Saint-Lambert, Brussels Capital, Belgium
- Ghent, Oost-Vlaanderen, Belgium
- Porto Alegre, Rio Grande do Sul, Brazil
- São Paulo, Brazil
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Shenzhen, Guangdong, China
- Shanghai, Shanghai Municipality, China
+ 29 more site(s).
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 Wilmington, Delaware, United States; St. Petersburg, Florida, United States; Chicago, Illinois, United States; Omaha, Nebraska, United States; Cincinnati, Ohio, United States; Fort Worth, Texas, United States and 43 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.