Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-24 @ 9:06 PM
NCT ID:
NCT01376804
Eligibility Criteria:
Inclusion Criteria:
* Children, 4 months to 16 years of age
* Patient has received a kidney transplant
* At risk of developing cytomegalovirus disease
* Adequate hematological and renal function
* Able to tolerate oral medication
* Negative pregnancy test for females of childbearing potential
Exclusion Criteria:
* Allergic or significant adverse reaction to acyclovir, valacyclovir or ganciclovir in the past
* Severe uncontrolled diarrhea (more than 5 watery stools per day)
* Liver enzyme elevation of more than five times the upper limit of normal for aspartate aminotransferase \[AST (SGOT)\] or alanine aminotransferase \[ALT (SGPT)\]
* Patient requires use of any protocol prohibited concomitant medication
* Previous participation in this clinical study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Months
Maximum Age:
16 Years
Study:
NCT01376804
Study Brief:
Protocol Section:
NCT01376804