Back to resultsA Study of Valcyte (Valganciclovir) Syrup Formulation in Pediatric Solid Organ Transplant Recipients
Primary Purpose
Cytomegalovirus Infections
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
valganciclovir [Valcyte]
Sponsored by
About this trial
This is an interventional treatment trial for Cytomegalovirus Infections
Eligibility Criteria
Inclusion Criteria: patients between 3 months and 16 years of age; first solid organ transplant (eg, kidney, liver, heart); able to tolerate oral medication; females of childbearing potential must agree to utilize an effective method of contraception throughout the study and for 90 days following discontinuation of study drug; patients at risk of developing CMV disease (all transplant recipients other than those who are D-R- for CMV). Exclusion Criteria: patients who have previously participated in this study; patients who are participating in another clinical trial (except with the approval of the Sponsor); severe, uncontrolled diarrhea (more than 5 watery stools per day); pregnant or lactating females.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Valganciclovir Age Group <= 2 Years
Valganciclovir Age Group >2 to <12 Years
Valganciclovir Age Group >= 12 Years
Arm Description
Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 milligrams (mg) once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose = 7 * body surface area (BSA) * creatinine clearance (CrCLS).
Eligible participants aged >2 to <12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose = 7 * BSA * CrCLS.
Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose = 7 * BSA * CrCLS.
Outcomes
Primary Outcome Measures
Mean Area Under the Concentration-Time Curve From 0 to 24 Hours of Valganciclovir
Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. The AUC 0-24 hours is area under the plasma concentration-time curve from time zero through 24 hours after dosing. A compartmental model was used to measure the plasma concentrations of valganciclovir. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant.
Number of Participants With Adverse Events Leading to Dose Interruption or Modification
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. The number of participants with AEs leading to dose interruptions or modifications are reported.
Number of Participants With Opportunistic Infections
Opportunistic infections included oral candidiasis, candidiasis, herpes simplex, cytomegalovirus antigen positive, cytomegalovirus test positive. The number of participants with opportunistic infections are reported.
Number of Participants With Any Adverse Events and Any Serious Adverse Events
An AE was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is any experience or a significant hazard, that is fatal, life-threatening, requires in-patient hospitalization or prolongation of existing one, results in persistent or significant disability, is a congenital anomaly, is medically significant or requires intervention to prevent one or other of the outcomes listed above.
Number of Participants With Adverse Events Leading to Discontinuation of the Study Drug
An AE was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. The number of participants with AEs leading to discontinuation of the study drug is reported.
Number of Participants With 3 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry
The number of participants experiencing a 3 grade shift (example from Grade 0 to Grade 3) from baseline (BL) in hematology and serum chemistry laboratory parameters are reported. The data was analyzed for overall study only.
Number of Participants With 4 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry
The number of participants experiencing a 4 grade shift (example from Grade 0 to Grade 4) from BL in hematology and serum chemistry laboratory parameters are reported. The data was analyzed for overall study only.
Secondary Outcome Measures
Number of Participants With Cytomegalovirus Disease Over Time
Cytomegalovirus (CMV) disease is defined as syndrome or tissue invasive disease in which CMV virus was identified in blood, urine, biopsy or other suitable specimen, which could be in conjunction with one or more of the following events: a) CMV syndrome was defined as virus present in blood or other suitable specimen, plus fever, and any of the following: leukopenia, atypical lymphocytosis, thrombopenia or elevated hepatic transaminases (for non-liver recipients). b) The diagnosis of organ specific tissue invasive CMV disease was evidence of CMV in the tissue (CMV inclusion bodies or in situ detection of CMV antigen or DNA), plus signs/symptoms of organ dysfunction.
Number of Participants With Treatment Failures
Treatment failure was defined as either the development of CMV (viremia, antigenemia or test positive) requiring treatment up to day 100 post-transplant (i.e, while undergoing prophylaxis with valganciclovir up to day 100) or discontinuation of study medication due to lack of efficacy or to toxicity.
Number of Participants Who Experienced Graft Loss
Graft loss was defined as impairment of organ function to such a degree that the participant died or underwent re-transplantation.
Mean Maximum Plasma Concentration of Valganciclovir Over Time
Maximum Plasma Concentration (Cmax) is defined as the maximum observed plasma concentration of Valganciclovir. Participants with kidney, liver and heart transplant were analyzed. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant.
Mean Elimination Half-Life of Valganciclovir Over Time
The Elimination Half-Life Period is defined as the time measured for the plasma concentration to decrease by half to its original concentration. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant. Here n represents number of participant with specific transplant i.e., kidney, liver, and heart.
Number of Participants Who Experienced Episodes of Rejection Over Time
Participants with biopsy proven active rejection are reported.
Full Information
NCT ID
NCT00090766
First Posted
September 3, 2004
Last Updated
September 14, 2016
Sponsor
Hoffmann-La Roche
1. Study Identification
Unique Protocol Identification Number
NCT00090766
Brief Title
A Study of Valcyte (Valganciclovir) Syrup Formulation in Pediatric Solid Organ Transplant Recipients
Official Title
Safety and Pharmacokinetics of Valganciclovir Syrup Formulation in Pediatric Solid Organ Transplant Recipients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
May 2005 (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 study will assess the safety and pharmacokinetics of Valcyte syrup in pediatric solid organ transplant recipients. The anticipated time on study treatment is 3-12 months and the target sample size is less than 100 individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Valganciclovir Age Group <= 2 Years
Arm Type
Experimental
Arm Description
Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 milligrams (mg) once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose = 7 * body surface area (BSA) * creatinine clearance (CrCLS).
Arm Title
Valganciclovir Age Group >2 to <12 Years
Arm Type
Experimental
Arm Description
Eligible participants aged >2 to <12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose = 7 * BSA * CrCLS.
Arm Title
Valganciclovir Age Group >= 12 Years
Arm Type
Experimental
Arm Description
Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose = 7 * BSA * CrCLS.
Intervention Type
Drug
Intervention Name(s)
valganciclovir [Valcyte]
Intervention Description
po daily (dose based on body surface area and CrCL)
Primary Outcome Measure Information:
Title
Mean Area Under the Concentration-Time Curve From 0 to 24 Hours of Valganciclovir
Description
Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. The AUC 0-24 hours is area under the plasma concentration-time curve from time zero through 24 hours after dosing. A compartmental model was used to measure the plasma concentrations of valganciclovir. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant.
Time Frame
Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day 7 to Day 14; Week 6, Week 10, and Week 14
Title
Number of Participants With Adverse Events Leading to Dose Interruption or Modification
Description
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. The number of participants with AEs leading to dose interruptions or modifications are reported.
Time Frame
Up to Week 26
Title
Number of Participants With Opportunistic Infections
Description
Opportunistic infections included oral candidiasis, candidiasis, herpes simplex, cytomegalovirus antigen positive, cytomegalovirus test positive. The number of participants with opportunistic infections are reported.
Time Frame
Up to Week 26
Title
Number of Participants With Any Adverse Events and Any Serious Adverse Events
Description
An AE was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is any experience or a significant hazard, that is fatal, life-threatening, requires in-patient hospitalization or prolongation of existing one, results in persistent or significant disability, is a congenital anomaly, is medically significant or requires intervention to prevent one or other of the outcomes listed above.
Time Frame
Up to Week 26
Title
Number of Participants With Adverse Events Leading to Discontinuation of the Study Drug
Description
An AE was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. The number of participants with AEs leading to discontinuation of the study drug is reported.
Time Frame
Up to Week 26
Title
Number of Participants With 3 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry
Description
The number of participants experiencing a 3 grade shift (example from Grade 0 to Grade 3) from baseline (BL) in hematology and serum chemistry laboratory parameters are reported. The data was analyzed for overall study only.
Time Frame
Up to Week 26
Title
Number of Participants With 4 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry
Description
The number of participants experiencing a 4 grade shift (example from Grade 0 to Grade 4) from BL in hematology and serum chemistry laboratory parameters are reported. The data was analyzed for overall study only.
Time Frame
Up to Week 26
Secondary Outcome Measure Information:
Title
Number of Participants With Cytomegalovirus Disease Over Time
Description
Cytomegalovirus (CMV) disease is defined as syndrome or tissue invasive disease in which CMV virus was identified in blood, urine, biopsy or other suitable specimen, which could be in conjunction with one or more of the following events: a) CMV syndrome was defined as virus present in blood or other suitable specimen, plus fever, and any of the following: leukopenia, atypical lymphocytosis, thrombopenia or elevated hepatic transaminases (for non-liver recipients). b) The diagnosis of organ specific tissue invasive CMV disease was evidence of CMV in the tissue (CMV inclusion bodies or in situ detection of CMV antigen or DNA), plus signs/symptoms of organ dysfunction.
Time Frame
Up to Week 26
Title
Number of Participants With Treatment Failures
Description
Treatment failure was defined as either the development of CMV (viremia, antigenemia or test positive) requiring treatment up to day 100 post-transplant (i.e, while undergoing prophylaxis with valganciclovir up to day 100) or discontinuation of study medication due to lack of efficacy or to toxicity.
Time Frame
Up to Week 26
Title
Number of Participants Who Experienced Graft Loss
Description
Graft loss was defined as impairment of organ function to such a degree that the participant died or underwent re-transplantation.
Time Frame
Up to Week 26
Title
Mean Maximum Plasma Concentration of Valganciclovir Over Time
Description
Maximum Plasma Concentration (Cmax) is defined as the maximum observed plasma concentration of Valganciclovir. Participants with kidney, liver and heart transplant were analyzed. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant.
Time Frame
Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day (D) 7 to D 14; and at Week (W) 6, W 10, and W 14
Title
Mean Elimination Half-Life of Valganciclovir Over Time
Description
The Elimination Half-Life Period is defined as the time measured for the plasma concentration to decrease by half to its original concentration. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant. Here n represents number of participant with specific transplant i.e., kidney, liver, and heart.
Time Frame
Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day 7 to Day 14; Week 6, Week 10, and Week 14
Title
Number of Participants Who Experienced Episodes of Rejection Over Time
Description
Participants with biopsy proven active rejection are reported.
Time Frame
Up to Week 26
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients between 3 months and 16 years of age;
first solid organ transplant (eg, kidney, liver, heart);
able to tolerate oral medication;
females of childbearing potential must agree to utilize an effective method of contraception throughout the study and for 90 days following discontinuation of study drug;
patients at risk of developing CMV disease (all transplant recipients other than those who are D-R- for CMV).
Exclusion Criteria:
patients who have previously participated in this study;
patients who are participating in another clinical trial (except with the approval of the Sponsor);
severe, uncontrolled diarrhea (more than 5 watery stools per day);
pregnant or lactating females.
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
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1752
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5124
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0297
Country
United States
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132-2806
Country
United States
City
Parkville
ZIP/Postal Code
3050
Country
Australia
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2R7
Country
Canada
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1S1
Country
Canada
City
Paris
ZIP/Postal Code
75019
Country
France
City
Paris
ZIP/Postal Code
75743
Country
France
City
Berlin
ZIP/Postal Code
13353
Country
Germany
City
Guadalajara
ZIP/Postal Code
44340
Country
Mexico
City
Mexico City
ZIP/Postal Code
06720
Country
Mexico
City
Madrid
ZIP/Postal Code
28041
Country
Spain
City
Madrid
ZIP/Postal Code
28046
Country
Spain
City
Valencia
ZIP/Postal Code
46009
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
A Study of Valcyte (Valganciclovir) Syrup Formulation in Pediatric Solid Organ Transplant Recipients
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