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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Timepoint [2] 0 0
Up to Week 26
Primary outcome [3] 0 0
Number of Participants With Opportunistic Infections
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
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
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
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
Timepoint [7] 0 0
Up to Week 26
Secondary outcome [1] 0 0
Number of Participants With Cytomegalovirus Disease Over Time
Timepoint [1] 0 0
Up to Week 26
Secondary outcome [2] 0 0
Number of Participants With Treatment Failures
Timepoint [2] 0 0
Up to Week 26
Secondary outcome [3] 0 0
Number of Participants Who Experienced Graft Loss
Timepoint [3] 0 0
Up to Week 26
Secondary outcome [4] 0 0
Mean Maximum Plasma Concentration of Valganciclovir Over Time
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
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
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
Sex
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
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
1/05/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2005
Sample size
Target
Accrual to date
Final
63
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/study/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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00090766