Phase II, Multicentric, Prospective and Opened Clinical Trial of Advance Valganciclovir Treatment of CMV in Allogenic Hematopoietic Progenitors Transplant
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 8
- 主要终点
- To value valganciclovir efficacy in advance treatment of CMV in patients received allogenic transplant with a uniform treatment.
研究概览
简要总结
PRINCIPAL ENDPOINT To value valganciclovir efficacy in advance treatment of CMV in patients received allogenic transplant with a uniform treatment.
SECONDARY ENDPOINT To value valganciclovir security in advance treatment of CMV in in patients received allogenic transplant with a uniform treatment.
The security will be valued by the % of patients that:
Will have negative CMV Neutropenia <1000 neutrophils/mm3 or <500 neutrophils/mm3 in the first 35 days of treatment - follow-up Renal toxicity in the first 35 days of treatment - follow-up (defined by elevated creatinine >1mg/dL or twice the basal value) CMV illness during the treatment or in the next 2 months Blood Antigenemia / PCR positive in the next 2months of treatment
This dates Hill be compared with a patients control group treated with intravenous valganciclovir
详细描述
Clinical trial with a drug in new conditions of use
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients > 18 years old
- •Any patients with allogenic TPH
- •Following in post-TPH with antigenemia or PCR-CMV
- •CMV in blood test detected by antigenemia or PCR before the day 180 post-TPH
- •The beginning of treatment must be Duch early as possible. Maximum in the 72 hours from the antigenemia or PCR-CMV detection
- •Be the first or second time of a CMV infection
- •Sign the informed consent
- •Pregnancy negative test in fertile age patients
排除标准
- •Patients received auto or syngenic TPH
- •Patients <50 kg weight
- •Known allergy or hypersensibility patients to valganciclovir, ganciclovir or aciclovir
- •Digestive intolerant: nauseous, vomit and or diarrhea that could difficult oral administration of valganciclovir
- •Patients that presents CMV infection or that is being evaluated for suspected CMV
- •Patients that have presented >2 CMV infection episode, before the current one
- •Severe liver disease defined by bilirubin ≥ 10mg/dL
- •Treated with: foscarnet, ganciclovir, cidofovir or another antiviral drug active to CMV, in the previous 30 days at the current episode
- •Neutrophils < 500 /µL at the beginning of valganciclovir treatment. Patients with >500 PMN/µL and < 1000/µL must start a G-CSF treatment to get neutrophils value > 1000/µL
- •Platelets < 25/mm3 even receiving transfusion
- •Clearance Creatinine < 10mL/min or dialysed patients
- •Pregnancy or lactant women
- •Other contraindication detailed in the "filling card"
- •Previous inclusión in this study at the treated group. Is allowed that a patient participate as a control case and after that receive valganciclovir treatment in after CMV episode
结局指标
主要结局
To value valganciclovir efficacy in advance treatment of CMV in patients received allogenic transplant with a uniform treatment.
时间窗: 1 year
次要结局
- To value valganciclovir security in advance treatment of CMV in in patients received allogenic transplant with a uniform treatment.(1 year)