EUCTR2004-000231-29-GB进行中（未招募）1 期
Safety and pharmacokinetics of valganciclovir syrup formulation in paediatric solid organ transplant recipients
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 63
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1.parent or guardian of patient willing and able to give written informed consent; the written assent from the child is also required if he/she is old enough to understand the risks and benefits of the study
- •2.patient has received a first solid organ transplant (e.g. liver, kidney, heart etc)
- •3.males or females aged between 3 months and 16 years
- •4.patient at risk of developing CMV disease (all transplant recipients other than those who are D-R- for CMV)
- •5.patient has adequate haematological and renal function as defined as:
- •a.Absolute neutrophil count (ANC) > 1300 cells/µL
- •b.Platelet count > 40,000 cells/µL
- •c.Haemoglobin > 8.0 g/dL
- •d.Estimated Schwartz creatinine clearance > 35 mL/min/1.73m2 (not applicable for kidney transplants) pre-transplant, and should be measured post transplant before study drug is initiated)
- •6.patient is able to tolerate oral medication (NG tube accepted unless patient expected to be dependant on NG tube beyond 1 week)
- •7.negative pregnancy test (blood or urine) for females of child bearing potential before initiation of valganciclovir treatment
- •8.patients of reproductive potential agree to utilize an effective method of contraception throughout the study period and for 90 days following discontinuation of study drug (abstinence is a valid method of contraception)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years)
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.patient has exhibited an allergic or other significant adverse reaction to acyclovir, valacyclovir or ganciclovir in the past
- •2.patient has severe, uncontrolled diarrhea (more than 5 watery stools per day)
- •3.patient has liver enzyme elevation of more than five times the upper limit of normal for AST (SGOT), or ALT (SGPT) (not applicable to liver or heart transplant patients)
- •4.patient requires use of any protocol prohibited concomitant medications
- •5.patient has previously participated in this clinical trial
- •6.patient is a lactating female who will not discontinue nursing prior to study entry
- •7.patient is simultaneously participating in another clinical trial except as approved by the sponsor
研究者
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