Clinical trial NCT00090766: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cytomegalovirus Infections
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2004-09-06
Enrollment: 63
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Mean Area Under the Concentration-Time Curve From 0 to 24 Hours of Valganciclovir
timeFrame: 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
measure: Number of Participants With Adverse Events Leading to Dose Interruption or Modification
timeFrame: Up to Week 26
measure: Number of Participants With Opportunistic Infections
timeFrame: Up to Week 26
measure: Number of Participants With Any Adverse Events and Any Serious Adverse Events
timeFrame: Up to Week 26
measure: Number of Participants With Adverse Events Leading to Discontinuation of the Study Drug
timeFrame: Up to Week 26
measure: Number of Participants With 3 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry
timeFrame: Up to Week 26
measure: Number of Participants With 4 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry
timeFrame: Up to Week 26
Secondary outcomes:
measure: Number of Participants With Cytomegalovirus Disease Over Time
timeFrame: Up to Week 26
measure: Number of Participants With Treatment Failures
timeFrame: Up to Week 26
measure: Number of Participants Who Experienced Graft Loss
timeFrame: Up to Week 26
measure: Mean Maximum Plasma Concentration of Valganciclovir Over Time
timeFrame: 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
measure: Mean Elimination Half-Life of Valganciclovir Over Time
timeFrame: 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
measure: Number of Participants Who Experienced Episodes of Rejection Over Time
timeFrame: Up to Week 26
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Indianapolis
country: United States
state: Indiana
city: Ann Arbor
country: United States
state: Michigan
city: St Louis
country: United States
state: Missouri
city: New York
country: United States
state: New York
city: Salt Lake City
country: United States
state: Utah
city: Parkville
country: Australia
city: Edmonton
country: Canada
state: Alberta
city: Winnipeg
country: Canada
state: Manitoba
city: Paris
country: France
city: Paris
country: France
city: Berlin
country: Germany
city: Guadalajara
country: Mexico
city: Mexico City
country: Mexico
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Valencia
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: