Status:
COMPLETED
A Study on the Pharmacokinetics and Safety of Valcyte (Valganciclovir) in Pediatric Heart Transplant Recipients Less Than 4 Months of Age
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Cytomegalovirus Infections, Heart Transplantation
Eligibility:
All Genders
Up to 124 years
Phase:
PHASE1
Brief Summary
This open label study will assess the pharmacokinetics and the safety and tolerability of Valcyte (valganciclovir) powder for oral solution in neonatal and infant heart transplant patients \< 4 months...
Eligibility Criteria
Inclusion
- Males and females, 0 to \< 4 months (\< 125 days) of age at the time of the last PK assessment in this study
- Parent or guardian of the patient is willing and able to give written informed consent
- Patient has received a first heart transplant
- Patient is at risk of developing cytomegalovirus (CMV) disease and is being treated with i.v. ganciclovir or oral valganciclovir for prevention of CMV
- Adequate hematological and renal function
- Able to tolerate oral medication (any appropriate form of tube feeding is acceptable)
Exclusion
- Allergic or significant adverse reaction to acyclovir, valacyclovir or ganciclovir in the past
- Severe, uncontrolled, clinically abnormal diarrhea
- Liver enzyme elevation of more than five times the upper limit of normal for AST (SGOT) or ALT (SGPT)
- Patient requires use of any protocol prohibited concomitant medications
- Patient has previously participated in this clinical trial
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01165580
Start Date
May 1 2011
End Date
September 1 2013
Last Update
November 2 2016
Active Locations (19)
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1
Loma Linda, California, United States, 92354
2
Palo Alto, California, United States, 94304
3
Aurora, Colorado, United States, 80045
4
Atlanta, Georgia, United States, 30322