NCT00016068已完成3 期
A Phase III Multicenter Study Of Valganciclovir For The Prevention Of Late Cytomegalovirus Infection After Allogeneic Hematopoietic Stem Cell Transplantation
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 13
- 主要终点
- Late cytomegalovirus infection by plasma PCR positivity
研究概览
简要总结
RATIONALE: Antivirals such as valganciclovir act against viruses and may be effective in preventing cytomegalovirus. It is not yet known if valganciclovir is effective in preventing cytomegalovirus.
PURPOSE: This randomized phase III trial is studying valganciclovir to see how well it works in preventing cytomegalovirus in patients who have undergone donor stem cell transplantation.
详细描述
OBJECTIVES:
Primary
- Compare cytomegalovirus (CMV) disease and non-CMV invasive infection-free survival in patients undergoing allogeneic hematopoietic stem cell transplantation treated with valganciclovir vs placebo.
- Compare the incidence of CMV disease in patients treated with these drugs.
- Compare the incidence of other severe invasive bacterial and fungal infections and overall survival in patients treated with these drugs.
Secondary
- Compare the incidence of CMV infection or disease at baseline and at days 270 and 640 after allogeneic hematopoietic stem cell transplantation in patients treated with these drugs.
- Compare the incidence of herpes simplex virus and varicella-zoster virus infections at baseline and day 270 in patients treated with these drugs.
- Determine the safety of valganciclovir in these patients.
- Compare the quality of life of patients treated with these drugs.
- Compare CMV-specific immune reconstitution in patients treated with these drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
- 盲法
- Double
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
结局指标
主要结局
Late cytomegalovirus infection by plasma PCR positivity
次要结局
未报告次要终点
研究者
研究点 (13)
Loading locations...
相似试验
已完成
3 期
Valacyclovir in Preventing Cytomegalovirus Infection in Patients Who Are Undergoing Donor Stem Cell TransplantationCancerNCT00045292Fred Hutchinson Cancer Center
终止
2 期
Randomized Controlled Trial of Valganciclovir for Cytomegalovirus Infected Hearing Impaired InfantsCmv CongenitalCMVCongenital CmvSNHLSensorineural Hearing LossNCT03107871Albert Park10
已完成
3 期
Comparison of Oral Valganciclovir and Placebo for the Prevention of Cytomegalovirus (CMV) After Lung TransplantationCytomegalovirus InfectionsNCT00227370Duke University136
已完成
2 期
Ganciclovir by Infusion and by Mouth in Treating Patients With Cytomegalovirus After Donor Bone Marrow TransplantMyelodysplastic/Myeloproliferative Neoplasm, UnclassifiableMDSMyelodysplastic/Myeloproliferative DiseasesMultiple MyelomaLymphomaLeukemiaNCT00530218City of Hope Medical Center61
已完成
3 期
A Phase III Study to Evaluate the Safety and Efficacy of Ganciclovir (Dihydroxypropoxymethyl Guanine [DHPG]) Treatment of Symptomatic Central Nervous System (CNS) Congenital Cytomegalovirus (CMV) Infections.Cytomegalovirus InfectionsNCT00001100National Institute of Allergy and Infectious Diseases (NIAID)130