EUCTR2015-004726-34-IT进行中（未招募）1 期
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 - NA
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 550
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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.
- •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 =2730 IU/mL to =273000 IU/mL in whole blood or =
- •910 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.
- •5.Have the current CMV infection as the first episode of CMV viremia after HSCT, either primary or reactivation.
- •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 =60mL/min/1.73m2
- •8.Have a negative serum beta human chorionic gonadotropin (ß-HCG)
- •pregnancy test at screening, if a
- •female of child bearing potential. Urine pregnancy tests may be done per institutional requirements;
- •however they are not sufficient for eligibility determination. Sexually active females of child bearing
- •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 treatment.
- •9.Be able to swallow tablets.
- •10.Have life expectancy of = 8 weeks.
- •11.Have weight =40 kg.
- •12.Be willing and have an understanding and ability to fully comply with study procedures and restrictions defined in the protocol.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 358
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 82
排除标准
- •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 requiring treatment 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, 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 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 cidofovir) for the current CMV infection for longer than 72 hours.
- •Note: A subject who is receiving these anti-CMV agents must discontinue their use before the first dose of study treatment. A subjects who may be receiving cidofovir must discontinue this antiviral at least 14 days prior
- •to randomization at Visit 2/Day 0 and the first dose of study treatment. Note: Subjects who were administered these anti-CMV agents for prophylaxis should have these treatments completed at least 2 weeks prior to the study entry or start of the treatment for current infection, whichever comes first, and have undetectable CMV DNA (based on local laboratory) for at
- •least 2 weeks between the completion of the anti-CMV prophylaxis and onset of the current infection.
- •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 aminotransfe
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