US•EN

Do You Have a Patient Who Has Received a Transplant and Has Been Diagnosed with Cytomegalovirus (CMV)?

If you have a patient who has received a hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT) and has been diagnosed with CMV, the Protego Study may be of interest.

Find a participating site

About the Protego Study

Study Purpose

The purpose of the Protego Study is to evaluate the pharmacokinetics, safety, tolerability, and anti-viral activity of an investigational drug, maribavir, for the treatment of CMV infection in children and adolescents who have received an HSCT or SOT.

Study Design

Screening period

Study treatment period

Follow-up period

This is a phase 3, open-label study that is enrolling approximately 80 participants. Participants will be enrolled into 1 of 3 cohorts based on age. The total duration of participation can last up to 22 weeks, including screening (up to 2 weeks), study treatment (8 weeks), and follow-up (12 weeks). Participants will be asked to attend up to 17 study site visits or home health care visits throughout their participation.

The investigational drug is administered twice daily as a tablet and must be swallowed as a whole, intact tablet. Participants who are not able to swallow a tablet may receive the investigational drug as a powder for oral suspension, when available.

The investigational drug, maribavir, is approved by the US Food and Drug Administration (FDA) for the treatment of certain types of post-transplant CMV infections in patients ages 12 and older in the United States and in adult patients in multiple additional countries, and is now being studied for children and adolescents under the age of 18 with post-transplant CMV infection.

Eligibility Criteria

Additional eligibility criteria apply.

Key Inclusion Criteria

  • Be a male or female child or adolescent < 18 years of age at the time of consent
    • Cohort 3 subjects (0 to < 6 years of age) must have a gestational age of at least 39 weeks and a minimum weight of 5 kg
  • Be a recipient of an HSCT or SOT that is functioning at the time of screening
  • 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 legally authorized representative (LAR) must meet this criterion
  • Be able to swallow a whole, intact tablet (unless the participant 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
  • Have life expectancy of ≥ 8 weeks
  • 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 ≥ 1,365 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 quantitative nucleic acid amplification test (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.

Key Exclusion Criteria

  • Have CMV tissue invasive disease involving the central nervous system (CNS) or retina as assessed by the investigator at the time of screening
  • Have previously received maribavir or CMV vaccine at any time
  • Have positive results for human immunodeficiency virus (HIV)
  • Be undergoing treatment for acute or chronic hepatitis B or hepatitis C
  • 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
  • Have serum aspartate aminotransferase > 5 × upper limit of normal (ULN) at screening, 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
  • 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
  • Require ongoing treatment with or an anticipated need for treatment with a strong CYP3A inducer

Refer a Patient

If you have a patient who may be interested and you think may qualify, refer them to any of the study sites listed here. The research staff members will be able to answer any questions you may have about the clinical research study. Each patient will be required to have a visit with the study doctor to further evaluate if he or she may qualify.

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