Back to resultsA Study on the Pharmacokinetics and Safety of Valcyte (Valganciclovir) in Pediatric Heart Transplant Recipients Less Than 4 Months of Age
Primary Purpose
Cytomegalovirus Infections, Heart Transplantation
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
valganciclovir [Valcyte]
Sponsored by
About this trial
This is an interventional prevention trial for Cytomegalovirus Infections, Heart Transplantation
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Outcomes
Primary Outcome Measures
Area under plasma concentration versus time curve of ganciclovir
Apparent volume of distribution of ganciclovir
Terminal half-life of ganciclovir
Peak concentration of ganciclovir
Secondary Outcome Measures
Safety (Incidence of adverse events)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01165580
Brief Title
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
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Infections, Heart Transplantation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
valganciclovir [Valcyte]
Intervention Description
oral dose, Days 1 and 2
Primary Outcome Measure Information:
Title
Area under plasma concentration versus time curve of ganciclovir
Time Frame
0, 1-3, 3-7, 7-12, 24 hours post-dose
Title
Apparent volume of distribution of ganciclovir
Time Frame
0, 1-3, 3-7, 7-12, 24 hours post-dose
Title
Terminal half-life of ganciclovir
Time Frame
0, 1-3, 3-7, 7-12, 24 hours post-dose
Title
Peak concentration of ganciclovir
Time Frame
0, 1-3, 3-7, 7-12, 24 hours post-dose
Secondary Outcome Measure Information:
Title
Safety (Incidence of adverse events)
Time Frame
9 days
10. Eligibility
Sex
All
Maximum Age & Unit of Time
124 Days
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
22710
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-9119
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1C9
Country
Canada
City
Madrid
ZIP/Postal Code
28007
Country
Spain
City
Madrid
ZIP/Postal Code
28046
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
A Study on the Pharmacokinetics and Safety of Valcyte (Valganciclovir) in Pediatric Heart Transplant Recipients Less Than 4 Months of Age
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