Tolerability of up to 200 Days of Valganciclovir Oral Solution or Tabletsin Pediatric Kidney Transplant Recipients - N/A

F. Hoffmann-La Roche Ltd.0 个研究点目标入组 50 人开始时间: 2011年5月25日最近更新: 2013年7月29日

适应症

试验速览

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•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

•1. Patient has exhibited an allergic or other significant adverse reaction to acyclovir, valacyclovir, ganciclovir or valganciclovir (or excipients) 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.

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