A Phase 3, Open-Label, Single-Arm Study to Assess the Efficacy, Safety, and Pharmacokinetics of Maribavir for the Treatment of Cytomegalovirus (CMV) Infection in Japanese Recipients of a Hematopoietic Stem Cell Transplant (HSCT) or Solid Organ Transplant (SOT)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 20
- 主要终点
- Number of Participants With TEAEs Leading to Treatment Discontinuation With Maribavir
研究概览
简要总结
The main aim of the study is to check if maribavir can treat Japanese people with Cytomegalovirus (CMV) infection, and to check side effect from the study treatment and how much maribavir participants can take without getting side effects from it.
Japanese recipients of a hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT) will take Maribavir tablets two times a day for 8 weeks in this study.
During the study, participants will visit their study clinic 18 times as a maximum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Maribavir
Maribavir 400 milligrams (mg), tablets, orally twice a day (BID) for up to 8 weeks.
干预措施: Maribavir (Drug)
结局指标
主要结局
Number of Participants With TEAEs Leading to Treatment Discontinuation With Maribavir
时间窗: From first dose of study drug up to Week 20
The number of participants with TEAEs leading to maribavir study treatment discontinuation (including treatment interruption or withdrawal) were reported.
Percentage of Participants Who Achieved Confirmed Clearance of Plasma CMV Deoxyribose Nucleic Acid (DNA) at Week 8
时间窗: At Week 8
The confirmed viremia clearance was defined as a plasma CMV DNA concentration below the lower limit of quantification (LLOQ) (that is \[i.e.\], less than \[\<\] 34.5 international units per milliliter \[IU/mL\]) when assessed by the COBAS® 8800/COBAS® CMV Test, in two consecutive post-baseline samples, separated by at least 5 days. To be considered a responder for the primary endpoint, the participant must have received exclusively study-assigned treatment (regardless of whether study-assigned treatment was completed).
Number of Participants With Clinically Meaningful Changes in Vital Signs
时间窗: From first dose of study drug up to Week 20
Vital sign assessments included blood pressure, pulse, respiratory rate and body temperature. Any clinically meaningful change in vital signs which were deemed clinically significant by the investigator were reported.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
时间窗: From first dose of study drug up to Week 20
A TEAEs was defined as any event emerging or manifesting at or after the initiation of treatment with an investigational product or medicinal product or any existing event that worsened in either intensity or frequency following exposure to the investigational product or medicinal product. An SAE was any untoward medical occurrence or effect that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability / incapacity, was a congenital anomaly / birth defect or was medically important due to other reasons than the above mentioned criteria.
Number of Participants With Clinically Meaningful Changes in Electrocardiograms (ECGs)
时间窗: From first dose of study drug up to Week 20
12-lead ECG were evaluated. Any change in ECG assessments which are deemed clinically meaningful by the investigator were reported.
Number of Participants With TEAEs of New Onset of Acute or Chronic Graft-versus-host Disease (GVHD), Graft Rejection, or Graft Loss
时间窗: From first dose of study drug up to Week 20
New onset of acute or chronic GVHD assessed as TEAEs, and graft rejection, or graft loss assessed were reported.
Number of Participants With Clinically Meaningful Abnormalities in Physical Examination Findings
时间窗: From first dose of study drug up to Week 20
Physical examination included assessments of the head, eyes, ears, nose, throat, neck, lymph nodes, and the cardiovascular, dermatological, musculoskeletal, respiratory, gastrointestinal, genitourinary, and neurological systems. Any clinically meaningful change in physical examination which were deemed clinically significant by the investigator were reported.
Number of Participants With Clinically Meaningful Abnormalities in Clinical Laboratory Parameters
时间窗: From first dose of study drug up to Week 20
Clinical laboratory parameters included evaluations of hematology, chemistry, urinalysis. Any clinically meaningful change in clinical laboratory parameters which were deemed clinically significant by the investigator were reported.
Number of Participants With Events of Immunosuppressant Drug Level Increased in Blood
时间窗: From first dose of study drug up to Week 8
Immunosuppressant drug concentration testing was solely for participants who received immunosuppressive therapy with tacrolimus, cyclosporine, or everolimus. The number of participants with an increased level of at least one immunosuppressant drug was reported.
次要结局
- Minimum Observed Plasma Concentration (Cmin) of Maribavir(At Weeks 1, 4, and 8: Pre-dose)
- Change From Baseline in Plasma CMV Viremia Load(Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12, 14, 16, 18 and 20)
- Percentage of Participants With Any Mutations in the CMV Genes Conferring Resistance to Maribavir(From first dose of study drug up to Week 20)
- Time to First Confirmed CMV Viremia Clearance(From first dose of study drug up to Week 20)
- Percentage of Participants With Recurrence of Confirmed CMV Viremia During Follow-up Period in Participants With Confirmed Viremia Clearance at Week 8 Who Required Additional Anti-CMV Treatment(From Week 9 up to Week 20)
- Percentage of Participants Who Maintained CMV Viremia Clearance and CMV Infection Symptom Control at Week 8 Through Weeks 12, 16 and 20(At Week 8 through Weeks 12, 16 and 20)
- Percentage of Participants With Recurrence of CMV Viremia During Study Treatment and in the Follow-Up Period After the Participants Are Discontinued From Study Treatment and While On/Off Study Assigned Treatment(Study treatment: Week 0 to Week 8; Follow-up Period:Week 9 to Week 20; At Any time during study:Week 0 to Week 20; While on study assigned treatment: Week 0 to EOT(Week 8 or earlier); While off study assigned treatment: EOT (Week 8 or earlier) to Week 20)
- Percentage of Participants Who Achieved Confirmed CMV Viremia Clearance at Week 8 to be Less Than (<) 137 IU/mL(At Week 8)