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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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00090766