EUCTR2015-004726-34-DEActive, not recruitingPhase 1
A Phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled study to assess the efficacy and safety of maribavir compared to valganciclovir for the treatment of cytomegalovirus (CMV) infection in hematopoietic stem cell transplant recipients.
Takeda Development Center Americas, Inc.0 sites550 target enrollmentStarted: June 30, 2017Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 550
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1.Be able to provide written, personally signed, and dated informed consent to participate in the study before completing any study-related procedures. As applicable, a parent/both parents or legally authorized representative (LAR) must provide signature of informed consent and there must be documentation of assent by the subject before completing any study-related procedures. During the COVID-19 public health emergency, informed consent from a potential or current trial participant may, if permitted by local laws and regulations, be obtained via electronic informed consent (eIC) capabilities or an electronic face-toface consent interview when these individuals are unable to travel to the site (FDA COVID-19 Guidance, 27 Jan 2021, Q11).
- •2.Be =16 years of age at the time of consent.
- •3.Be a recipient of hematopoietic stem cell transplant.
- •4.Have a documented asymptomatic CMV infection, with a screening value of CMV DNA =1365 IU/mL to =273000 IU/mL in whole blood or =455 IU/mL to = 91000 IU/mL in plasma in 2 consecutive assessments, separated by at least 1 day, as determined by local or central specialty laboratory quantitative polymerase chain reaction (qPCR) or comparable quantitative CMV DNA results. Both samples should be taken within 14 days prior to
- •randomization with second sample obtained within 5 days prior to randomization. Same laboratory and same sample type (whole blood or plasma) should be used for these assessments. Asymptomatic CMV infection is defined as an infection that does not present with tissue invasive CMV disease, as assessed by the investigator. Subjects with CMV DNA <910 and =455 IU/mL in plasma or <2730 and =1365 IU/mL in whole blood will also need to meet at least 1 of the following criteria for high-risk CMV infection to be eligible: - Human leukocyte antigen (HLA)-related (sibling) donor with at least 1 mismatch at 1 of the following 3 HLA-gene loci: HLA-A, -B or -DR, - Haploidentical donor, - Unrelated donor with at least 1 mismatch at 1 of the following 4 HLA-gene loci: HLA-A, -B, -C and DRB1, - Use of umbilical cord blood as stem cell source, - Use of ex vivo T-cell-depleted grafts, - Grade 2 or greater GVHD, requiring the use of systematic corticosteroids (defined as the use of =1 mg/kg/day of prednisone or equivalent dose of another corticosteroid).
- •5.Have the current CMV infection as the first episode of CMV viremia after HSCT, either primary or reactivation, which in the investigator's opinion requires treatment.
- •6.Per investigator’s judgment, be eligible for treatment with valganciclovir.
- •7.Have all of the following results as part of screening laboratory assessments (results from either the central laboratory or a local laboratory can be used for qualification):
- •a.Absolute neutrophil count =1000/mm3 [1.0 x 109/L]
- •b.Platelet count =25,000/mm3 [25 x 109/L]
- •c.Hemoglobin =8g/dL.
- •d.Estimated creatinine clearance =30mL/min
- •8.Have a negative serum beta human chorionic gonadotropin (ß-hCG) pregnancy test at screening, if a
- •female of childbearing potential. Urine pregnancy tests may be done per institutional requirements;
- •however they are not sufficient for eligibility determination. Sexually active females of childbearing
- •potential must agree to comply with any applicable contraceptive requirements of the protocol. If male,
- •must agree to use an acceptable method of birth control, as defined in the protocol, during the study
- •treatment administration period and for 90 days afterward the last dose of study tr
Exclusion Criteria
- •1. Have CMV tissue invasive disease as assessed by the investigator at the time of screening and randomization at Visit 2/Day 0.
- •2. Have a CMV infection that is known to be genotypically resistant to ganciclovir, valganciclovir, foscarnet, or cidofovir based on documented evidence.
- •3. Be presenting with recurrent CMV infection (defined as a new detection of CMV infection in a subject who had at least one previously documented episode of CMV infection post-transplant, and who has had at least 2 weeks of undetectable CMV DNA between the episodes (during active surveillance, based on same local laboratory and same sample type). The subject must also have been off any anti-CMV treatment between the current and prior infection. Otherwise, the current infection may be considered continuation of the prior infection.
- •4. Require ganciclovir, valganciclovir, foscarnet, or cidofovir administration for conditions other than CMV when study treatment is initiated (example: herpes simplex virus [HSV] co-infection requiring use of any of these agents after the randomization) or would need a co-administration with maribavir for CMV infection.
- •5. Be receiving leflunomide, letermovir or artesunate when study treatment is initiated. NOTE: Subjects who may be receiving leflunomide must discontinue the use at least 14 days prior to randomization at Visit 2/Day 0 and the first dose of study treatment. Subjects receiving letermovir must discontinue use 3 days prior to first dose of study treatment. Subjects receiving artesunate must discontinue the use prior to the first dose of study treatment.
- •6. Be on treatment with anti-CMV agents (ganciclovir, valganciclovir, foscarnet or letermovir) for the current CMV infection for longer than 72 hours.
- •7. Have known hypersensitivity to the active substance or to an excipient of the study treatments.
- •8. Have severe vomiting, diarrhea, or other severe gastrointestinal illness within 24 hours prior to the first dose of study treatment that would preclude administration of oral medication.
- •9. Require mechanical ventilation or vasopressors for hemodynamic support at the time of randomization.
- •10. Be female and pregnant or nursing.
- •11. Have previously completed, discontinued, or have been withdrawn from this study.
- •12. Have received any investigational agent with known anti-CMV activity within 30 days before initiation of
- •study treatment or CMV vaccine at any time.
- •13. Have received any unapproved agent or device within 30 days before initiation of study treatment.
- •14. 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 assigned study treatment, or compromise the safety or well-being of the subject.
- •15. Have previously received maribavir.
- •16. Have serum aspartate aminotransferase (AST) >5 times upper limit of normal (ULN) at screening, or serum alanine aminotransferase (ALT) >5 times ULN at screening, or total bilirubin =3.0 x ULN at screening (except for documented Gilbert’s syndrome), as analyzed by local or central laboratory.
- •17. Have known (previously documented) positive results for human immunodeficiency virus (HIV). Subjects must have confirmed negative HIV test result within 3 month of study entry or, in unavailable, be tested by a local laboratory during the screening period.
- •18. Have active malignancy with the exception of nonmelanoma skin cancer, as determined by the inves
Investigators
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