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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00090766




Registration number
NCT00090766
Ethics application status
Date submitted
3/09/2004
Date registered
6/09/2004
Date last updated
31/10/2016

Titles & IDs
Public title
A Study of Valcyte (Valganciclovir) Syrup Formulation in Pediatric Solid Organ Transplant Recipients
Scientific title
Safety and Pharmacokinetics of Valganciclovir Syrup Formulation in Pediatric Solid Organ Transplant Recipients
Secondary ID [1] 0 0
WV16726
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cytomegalovirus Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - valganciclovir [Valcyte]

Experimental: Valganciclovir Age Group <= 2 Years - 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).

Experimental: Valganciclovir Age Group >2 to <12 Years - 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.

Experimental: Valganciclovir Age Group >= 12 Years - 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.


Treatment: Drugs: valganciclovir [Valcyte]
po daily (dose based on body surface area and CrCL)

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
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
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Up to Week 26
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0
Up to Week 26
Primary outcome [4] 0 0
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.
Timepoint [4] 0 0
Up to Week 26
Primary outcome [5] 0 0
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.
Timepoint [5] 0 0
Up to Week 26
Primary outcome [6] 0 0
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.
Timepoint [6] 0 0
Up to Week 26
Primary outcome [7] 0 0
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.
Timepoint [7] 0 0
Up to Week 26
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Up to Week 26
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Up to Week 26
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Up to Week 26
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
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
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
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
Secondary outcome [6] 0 0
Number of Participants Who Experienced Episodes of Rejection Over Time - Participants with biopsy proven active rejection are reported.
Timepoint [6] 0 0
Up to Week 26

Eligibility
Key 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).
Minimum age
3 Months
Maximum age
16 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2/Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Parkville
Recruitment postcode(s) [1] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Utah
Country [7] 0 0
Canada
State/province [7] 0 0
Alberta
Country [8] 0 0
Canada
State/province [8] 0 0
Manitoba
Country [9] 0 0
France
State/province [9] 0 0
Paris
Country [10] 0 0
Germany
State/province [10] 0 0
Berlin
Country [11] 0 0
Mexico
State/province [11] 0 0
Guadalajara
Country [12] 0 0
Mexico
State/province [12] 0 0
Mexico City
Country [13] 0 0
Spain
State/province [13] 0 0
Madrid
Country [14] 0 0
Spain
State/province [14] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00090766
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications