EUCTR2010-022514-47-ES进行中（未招募）1 期
Tolerability of up to 200 Days of Valganciclovir Oral Solution or Tablets in Pediatric Kidney Transplant Recipients - N/A
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
- 57
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
- 性别
- All
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 kidney transplant.
- •3. Males or females aged between 4 months and = 16 years.
- •4. Patient at risk of developing CMV disease (including R+ who are at risk of CMV due to other factors determined by the treating physician).
- •5. Patient has adequate hematological and renal function defined as:
- •Absolute neutrophil count (ANC) >1300 cells/µL
- •Platelet count >40,000 cells/µL
- •Hemoglobin >8.0 g/dL
- •Estimated Schwartz creatinine clearance (>15 mL/min) to allow for dosing according to algorithm 6. Patient is able to tolerate oral medication (any standard practice tube feeding is acceptable).
- •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: 50
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •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).
- •4. Patient requires use of any protocol prohibited concomitant medications.
- •5. Patient has previously participated in this clinical study.
- •6. Patient is a lactating female who will not discontinue nursing prior to study entry.
- •7. Patient is simultaneously participating in another clinical study except as approved by the Sponsor.
研究者
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4 期
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