Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for CMV Infection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of Patients With Late CMV Disease
研究概览
简要总结
The purpose of the study is to assess the incidence and severity of late Cytomegalovirus (CMV) disease, defined as CMV syndrome or tissue invasive disease occurring between 100 and 200 days and after 200 days post-transplant in patients treated with valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant versus valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant.
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
- None
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
- •Male and female patients ≥ 18 years of age.
- •Male or female patients who CMV seronegative receiving a kidney, pancreas or liver from a seropositive donor.
- •Female patients of child bearing potential must have a negative urine or serum pregnancy test within the past 48 hours prior to receiving transplant or study inclusion.
- •The patient has given written informed consent to participate in the study.
排除标准
- •Solid organ transplant recipient is CMV seropositive at the time of transplant.
- •Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV).
- •Patient has uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives.
- •Patients with thrombocytopenia (<25,000/mm3 ), with an absolute neutrophil count of < 1,000/mm3); and/or leucopoenia (< 2,000/mm3), or anemia (hemoglobin < 6 g/dL) prior to study inclusion.
- •Patient is taking or has been taking an investigational drug in the 30 days prior to transplant.
- •Patient has a known hypersensitivity to valganciclovir, tacrolimus, mycophenolate mofetil, rabbit anti-thymocyte globulin, CMV hyperimmune globulin, basiliximab or corticosteroids.
- •Patients with severe diarrhea or other gastrointestinal disorders that might interfere with their ability to absorb oral medication.
- •Patient is pregnant or lactating, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by positive human Chorionic Gonadotropin (hCG) laboratory test.
- •Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator.
- •Inability to cooperate or communicate with the investigator.
研究组 & 干预措施
Valcyte
valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant
干预措施: Valganciclovir (Drug)
Valcyte then Cytogam
valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant for prophylaxis against CMV infection
干预措施: CMV hyperimmune globulin (Biological)
Valcyte then Cytogam
valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant for prophylaxis against CMV infection
干预措施: Valganciclovir (Drug)
结局指标
主要结局
Number of Patients With Late CMV Disease
时间窗: after 200 days post-transplant until 2 years post-transplant
Number of any clinically significant late CMV disease, defined as CMV syndrome or tissue-invasive disease occurring after the first 200 days post transplant
次要结局
- Number of Patients With Early CMV Infection(100 days)
- Number of Patients With Cell Mediated Immunity(2 years)
- Number of Participants With Acute Cellular and/or Antibody Mediated Rejection(2 years)
- Renal Function(6, 12, and 24 months after transplant)
- Number of Participants With Opportunistic Infections(2 years)
- Number of Participants With Asymptomatic CMV Viremia(2 years)
- Number of Participants With CMV Seroconversions(2 years)