Authorised Therapeutic confirmatory (Phase III) Cytomegalovirus (CMV) infection in children and adolescents who have received a hematopoietic stem cell transplant (HSCT) or a solid organ transplant (SOT)

A study to test the safety, dosage and effectiveness of maribavir for the treatment of cytomegalovirus (CMV) infection in children and adolescents who have received transplant

EU CTIS ID: 2023-508988-73-00

What this study is testing

"1. To characterize the pharmacokinetics (PK) of maribavir and identify dosing regimens for CMV infection treatment in pediatric HSCT and SOT subjects from 0 years to <18years of age. 2. To assess the safety and tolerability of maribavir in children and adolescents."

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 1. Parent/both parents or LAR must provide signature of informed consent and there must be documentation of assent by the subject, as age appropriate, before completing any study-related procedures.
  • "9. Have life expectancy of ≥8 weeks. "
  • 11.      Subjects must have a confirmed negative 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.
  • "10. 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. "
  • 2. Be a male or female child or adolescent <18 years of age at the time of consent; for subjects in Cohort 3 only (0 to <6 years),, must have a minimum gestational age of at least 39 weeks and minimum weight of 5 kg.
  • "3. Be a recipient of an SOT or an HSCT that is functioning at the time of screening."

You likely can't join if

  • "Subjects must not: 1.Have CMV tissue invasive disease involving the central nervous system or retina as assessed by the investigator at the time of screening."
  • 10.Have received an 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 approved agents under investigation for additional indications are not exclusionary.
  • "11.Have previously received maribavir or CMV vaccine at any time. "
  • "12.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 compromise the safety or well-being of the subject."
  • 13.Have severe liver disease (Child-Pugh score of ≥10).
  • 14.Have serum aspartate aminotransferase >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 (except for documented Gilbert's syndrome), as analyzed by local laboratory.
See the full eligibility criteria
Who can join
  • 1. Parent/both parents or LAR must provide signature of informed consent and there must be documentation of assent by the subject, as age appropriate, before completing any study-related procedures.
  • "9. Have life expectancy of ≥8 weeks. "
  • 11.      Subjects must have a confirmed negative 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.
  • "10. 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. "
  • 2. Be a male or female child or adolescent <18 years of age at the time of consent; for subjects in Cohort 3 only (0 to <6 years),, must have a minimum gestational age of at least 39 weeks and minimum weight of 5 kg.
  • "3. Be a recipient of an SOT or an HSCT that is functioning at the time of screening."
  • 4. 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 IU/mL in whole blood or ≥455 IU/mL in plasma in 2 consecutive assessments separated by at least 1 day, as determined by local laboratory qPCR or comparable qNAAT results. Quantitative assays must be standardized to the World Health Organization (WHO) CMV International Standard. Both samples must be taken within 14 days of first dose of study drug with the second sample obtained within 5 days prior to first dose of study drug. The same laboratory and same sample type (whole blood or plasma) must be used for both assessments. If a documented and verified value is available in medical history that fulfills this criterion entirely, it may be used instead.
  • 5. Have all the following results as part of screening laboratory assessments: a. Absolute neutrophil count ≥500/mm3 (0.5 × 10^9/L) b. Platelet count ≥15,000/mm3 (15 × 10^9/L) c. Hemoglobin ≥8 g/dL. (≥80 g/L).
  • 6. Have an estimated glomerular filtration rate (creatinine based Bedside Schwartz equation) ≥30 mL/min/1.73 m^2.
  • "7. Be a female of nonchildbearing potential. If a female of childbearing potential, have a negative serum human chorionic gonadotropin (hCG) or beta-hCG (β-hCG) pregnancy test at screening. Males, or nonpregnant, nonlactating females who are sexually active must agree to comply with the applicable contraceptive requirements of this protocol during the study treatment administration period and for 90 days after the last dose of study treatment."
  • 8. Be able to swallow a whole, intact tablet (unless the subject has a feeding tube, such as a nasogastric [NG] or orogastric [OG] tube, in which case a crushed tablet or the powder-for-oral-suspension formulation can be administered) or be able to swallow an oral suspension.
What rules you out
  • "Subjects must not: 1.Have CMV tissue invasive disease involving the central nervous system or retina as assessed by the investigator at the time of screening."
  • 10.Have received an 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 approved agents under investigation for additional indications are not exclusionary.
  • "11.Have previously received maribavir or CMV vaccine at any time. "
  • "12.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 compromise the safety or well-being of the subject."
  • 13.Have severe liver disease (Child-Pugh score of ≥10).
  • 14.Have serum aspartate aminotransferase >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 (except for documented Gilbert's syndrome), as analyzed by local laboratory.
  • 15.Have positive results for human immunodeficiency virus (HIV).
  • 16.Have active malignancy with the exception of nonmelanoma skin cancer, as determined by the investigator. Subjects who experience relapse or progression of their underlying malignancy (for which HSCT or SOT was performed), as determined by the investigator, are not to be enrolled.
  • 17.Be undergoing treatment for acute or chronic hepatitis B or hepatitis C.
  • 18. Requiring ongoing treatment with or an anticipated need for treatment with a strong CYP3A inducer.
  • 19. Have a low body weight where total blood volume (TBV) required during study participation will exceed 1% TBV per study visit or 3% TBV over a 4 week period (see Section 8.2.4.3 and Appendix 3 for blood collection volumes and TBV determination).
  • 2.Have uncontrolled other type of infection as assessed by the investigator on the date of enrollment.
  • 3.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.
  • 4.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.
  • 5.Have a known hypersensitivity to maribavir or to any excipients.
  • 6.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 medication.
  • 7.Require mechanical ventilation or vasopressors for hemodynamic support at baseline(Visit2/Day1/Week0).
  • 8.Be pregnant (or expecting to conceive) or nursing.
  • 9.Have previously completed, discontinued, or have been withdrawn from this study.

The study team makes the final eligibility decision.

Where it's taking place

  • Japan
  • Brazil
  • United Kingdom
  • Australia
  • United States
  • China
  • Israel

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, 0-17 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Japan; Brazil; United Kingdom; Australia; United States; China and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.