The purposes of this study are to describe the safety and tolerability profile of valganciclovir syrup and tablets in pediatric solid organ transplant recipients, to determine the pharmacokinetics (the body's absorption, distribution, metabolism, and excretion) of ganciclovir following oral administration of valganciclovir syrup and tablets in pediatric solid organ transplant recipients, and to describe the incidence of CMV disease.

Condition	Treatment or Intervention	Phase
Cytomegalovirus Infection	Drug: valganciclovir hydrochloride	Phase II

Ages Eligible for Study:  3 Months   -   16 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• 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
• Patient has received a first solid organ transplant (e.g. kidney, liver, heart, etc)
• Males or females aged between 3 months and 16 years (i.e. age greater than or equal to 3 months, or age less than or equal to 16 years)
• Patient at risk of developing CMV disease (all transplant recipients other than those who are D-/R- for CMV)
• Patient has adequate hematological (blood test results) and renal (kidney) function
• Patient is able to tolerate oral medication (any standard practice tube feeding is acceptable)
• Negative pregnancy test for females of child bearing potential (blood or urine) before initiation of valganciclovir treatment
• Patients of reproductive potential agree to utilize an effective method of contraception (birth control) throughout the study period and for 90 days following discontinuation of study drug (abstinence is a valid method of contraception)

Exclusion Criteria:

• Patient has exhibited an allergic or other significant adverse reaction to acyclovir, valacyclovir or ganciclovir in the past
• Patient has severe, uncontrolled diarrhea (more than 5 watery stools per day)
• 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 recipients)
• Patient requires use of any protocol prohibited concomitant (accompanying) medications
• Patient has previously participated in this clinical trial
• Patient is a lactating female who will not discontinue nursing prior to study entry
• Patient is simultaneously participating in another clinical trial, except as approved by the Sponsor

Please reference Study ID Number: PDO-WV16726      973-235-5000 
or      800-526-6367 (FOR US ONLY) 

California
      Los Angeles,  California,  90095-1752,  United States; Recruiting
Indiana
      Indianapolis,  Indiana,  46202-5124,  United States; Recruiting
Michigan
      Ann Arbor,  Michigan,  48109-0297,  United States; Recruiting
Missouri
      St. Louis,  Missouri,  63110,  United States; Recruiting
New York
      New York,  New York,  10029,  United States; Recruiting
Ohio
      Cincinnati,  Ohio,  45229-3039,  United States; Recruiting
Pennsylvania
      Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting
Utah
      Salt Lake City,  Utah,  84132-2806,  United States; Recruiting
Australia
      Parkville,  3052,  Australia; Recruiting
      Westmead,  2145,  Australia; Recruiting
Canada, Alberta
      Edmonton,  Alberta,  T6G 2R7,  Canada; Recruiting
Canada, Manitoba
      Winnipeg,  Manitoba,  R3A 1S1,  Canada; Recruiting
Canada, Ontario
      Toronto,  Ontario,  M5G 1X8,  Canada; Terminated
France
      Paris,  75743,  France; Recruiting
      Paris,  75019,  France; Recruiting
      Lyon,  69437,  France; Recruiting
      Lyon,  69437,  France; Terminated
Germany
      Berlin,  13353,  Germany; Recruiting
      Berlin,  13353,  Germany; Not yet recruiting
Mexico
      Mexico City,  06720,  Mexico; Recruiting
      Guadalajara,  44340,  Mexico; Recruiting
Spain
      Madrid,  28046,  Spain; Recruiting
      Madrid,  28041,  Spain; Recruiting
      Valencia,  46009,  Spain; Recruiting
United Kingdom
      Nottingham,  NG2 3HF,  United Kingdom; Completed
      Birmingham,  B4 6NH,  United Kingdom; Not yet recruiting
      Glasgow,  G3 8SJ,  United Kingdom; Not yet recruiting

Study ID Numbers:  WV16726
Record last reviewed:  March 2005
Last Updated:  March 25, 2005
Record first received:  September 3, 2004
ClinicalTrials.gov Identifier:  NCT00090766
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08