A Randomized, Double-blind Study To Assess The Efficacy And Safety Of Prophylactic Use Of Maribavir Versus Oral Ganciclovir For The Prevention Of Cytomegalovirus Disease In Recipients Of Orthotopic Liver Transplants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 307
- 试验地点
- 55
- 主要终点
- Number of Participants With Endpoint Committee (EC)-Confirmed Cytomegalovirus (CMV) Disease Within 6 Months Post-Transplantation
研究概览
简要总结
The purpose of this research study is to investigate whether or not oral maribavir is safe and effective compared to oral ganciclovir for preventing CMV disease when administered for up to 14 weeks in patients who have had a liver transplant.
详细描述
Cytomegalovirus (CMV) infections remain a significant problem following various types of transplants that are associated with strong immunosuppressive therapy. Maribavir is a new oral anti-CMV drug with a novel mechanism of action compared to currently available anti-CMV drugs. This study will test the safety and efficacy of maribavir for the prevention of CMV disease when given as prophylaxis for up to 14 weeks following orthotopic liver transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Orthotopic liver transplant recipient
- •Donor CMV seropositive / Recipient CMV seronegative
- •Enrolled within 10 days after liver transplant
- •Able to swallow tablets
排除标准
- •Multiple organ transplant
- •HIV infection
- •CMV disease
- •Use of other anti-CMV therapy at time of enrollment
研究组 & 干预措施
1
干预措施: maribavir (Drug)
2
干预措施: ganciclovir (Drug)
结局指标
主要结局
Number of Participants With Endpoint Committee (EC)-Confirmed Cytomegalovirus (CMV) Disease Within 6 Months Post-Transplantation
时间窗: 6 months post-transplant
All investigator-determined (protocol-defined) cases of CMV disease (i.e., symptomatic CMV infection or CMV organ disease), were adjudicated by an independent, blinded EC. Symptomatic CMV infection was defined as: CMV infection detected by a positive result from a CMV laboratory assay from at least one central laboratory assay (pp65 antigenemia or CMV DNA polymerase chain reaction \[PCR\] assay in plasma) and fever \>/=38 °C on \>/=2 occasions \>/=24 hours apart within a 7-day period and at least one of the following: new or increased malaise, two successive measurements of leucopenia (white blood cell \[WBC\] count \<3500/mm3 or a WBC count decrease of 20% if the cell count prior to onset of clinical symptoms was \>4000/mm3) \>/=24 hours apart, atypical lymphocytosis \>/=5%, and thrombocytopenia. CMV organ disease was defined as described by Ljungman et al., 2002.
次要结局
- Number of Participants With Investigator-determined CMV Disease(Through 6 months post-transplant (Day 1 to 100 days and 6 months post-transplant))
- Number of Participants Who Died Within 6 Months Post-Transplantation(6 months post-transplant)
- Percent of Participants With Signs of Bone Marrow Suppression(15 weeks)
- Plasma Concentration of Maribavir During Treatment(12 hours post-dose after 2, 6, and 10 weeks of treatment)
- Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation(6 months post-transplant)
- Time to Onset of CMV Infection or EC-confirmed CMV Disease Within 6 Months Post-Transplantation(6 months post-transplant)
- Number of Participants With Retransplantation(Through 6 months post-transplant (From Day 1 to 100 days and 6 months post-transplant))
- Number of Participants With EC-confirmed CMV Disease Within 100 Days Post-Transplantation(100 days post-transplant)
- Number of Participants With Graft Failure Related Death(Through 6 months post-transplant (From Day 1 to 100 days and 6 months post-transplant))
- Number of Participants With Acute Graft Rejection(26 weeks post-transplant)
- Number of Participants With CMV Infection or EC-confirmed CMV Disease Within 100 Days Post-Transplantation(100 days post-transplant)
- Plasma Concentration of Maribavir Metabolite VP 44469 During Treatment(12 hours post-dose after 2, 6, and 10 weeks of treatment)