NCT01185223终止3 期
Multicenter, Randomized Study Comparing Oral Valganciclovir Versus Intravenous Ganciclovir in Patients Following Allogeneic Stem Cell Transplantation
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 212
- 试验地点
- 17
- 主要终点
- Efficacy and Safety of oral valganciclovir versus intravenous ganciclovir
研究概览
简要总结
The objective of this study is to assess the efficacy and safety of oral valganciclovir versus intravenous ganciclovir in patients following allogenic stem cell 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
- 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
- •Patient following allogeneic SCT
- •Patient with a first episode of positive CMV-PCR (DNAemia) or pp65 antigenemia assay (antigenemia) up to 100 days after SCT
- •Absolute neutrophil count (ANC) ≥1000 cells/µL on 2 consecutive follow-ups within 10 days before randomization
- •Patient has a creatinine clearance of ≥25 mL/min (calculated by the Cockcroft-Gault formula, see Part I Section 6.1.2) with evidence of improving renal function,
- •None or gastrointestinal graft-versus-host disease (GVHD) up to grade 2
排除标准
- •Patient has a suspected or diagnosed CMV disease
- •Patient has received syngeneic SCT
- •Patient who received an investigational medicinal product (IMP) within the last 30 days prior to screening or who is simultaneously participating in another clinical study with an IMP
- •Patient with a body weight <50 kg or >95 kg,
- •Patient has received anti-CMV therapy within the past 30 days prior to screening (the use of acyclovir, valacyclovir, or famciclovir is permitted)
- •Patient who has participated in this study before,
- •Patient who shows a neutropenia, thrombocytopenia, or anemia within 10 days before or at the time point of randomization as following:
- •The ANC is <1000 cells/μL on 2 consecutive follow-ups, or
- •A platelet count of ≥25000/μL can not be achieved/maintained with platelet transfusions
- •A hemoglobin level of ≥8g/dL can not be achieved/maintained by red blood cell transfusions
研究组 & 干预措施
Valganciclovir
Other
干预措施: Valganciclovir (Drug)
Ganciclovir
Active Comparator
干预措施: Ganciclovir (Drug)
结局指标
主要结局
Efficacy and Safety of oral valganciclovir versus intravenous ganciclovir
时间窗: max. 2 years (recruitement time)
Main variable for efficacy in the primary endpoint will be evaluated by assessment of the event-free survival within 180 days after stem cell transplantation. Main variable for safety in the primary endpoint will be evaluated by the porpotion of patients with severe neutropenia until 7 days after discontinuation of antiviral therapy with the study drug.
次要结局
- Combined secondary endpoint of efficacy and safety(max. 2 years (recruitement time))
研究者
研究点 (17)
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