Clinical trial NCT01165580: A Study on the Pharmacokinetics and Safety of Valcyte (Valganciclovir) in Pediatric Heart Transplant Recipients Less Than 4 Months of Age
Official title: Pharmacokinetics and Safety of Valganciclovir in Pediatric Heart Transplant Recipients < 4 Months of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cytomegalovirus Infections, Heart Transplantation
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-07-20
Enrollment: 17
Sex: ALL
Maximum age (years): 124
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 of age.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Area under plasma concentration versus time curve of ganciclovir
timeFrame: 0, 1-3, 3-7, 7-12, 24 hours post-dose
measure: Apparent volume of distribution of ganciclovir
timeFrame: 0, 1-3, 3-7, 7-12, 24 hours post-dose
measure: Terminal half-life of ganciclovir
timeFrame: 0, 1-3, 3-7, 7-12, 24 hours post-dose
measure: Peak concentration of ganciclovir
timeFrame: 0, 1-3, 3-7, 7-12, 24 hours post-dose
Secondary outcomes:
measure: Safety (Incidence of adverse events)
timeFrame: 9 days
Other outcomes:
Locations:
city: Loma Linda
country: United States
state: California
city: Palo Alto
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Atlanta
country: United States
state: Georgia
city: Ann Arbor
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Saint Louis
country: United States
state: Missouri
city: Bronx
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Charleston
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Seattle
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
city: Edmonton
country: Canada
state: Alberta
city: Madrid
country: Spain
city: Madrid
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: