A Study of Valcyte (Valganciclovir) Syrup Formulation in Pediatric Solid Organ Transplant Recipients
NCT ID: NCT00090766
Last Updated: 2016-10-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
63 participants
INTERVENTIONAL
2004-05-31
2005-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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).
valganciclovir [Valcyte]
po daily (dose based on body surface area and CrCL)
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.
valganciclovir [Valcyte]
po daily (dose based on body surface area and CrCL)
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.
valganciclovir [Valcyte]
po daily (dose based on body surface area and CrCL)
Interventions
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valganciclovir [Valcyte]
po daily (dose based on body surface area and CrCL)
Eligibility Criteria
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Inclusion Criteria
* 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 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.
3 Months
16 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Los Angeles, California, United States
Indianapolis, Indiana, United States
Ann Arbor, Michigan, United States
St Louis, Missouri, United States
New York, New York, United States
Salt Lake City, Utah, United States
Parkville, , Australia
Edmonton, Alberta, Canada
Winnipeg, Manitoba, Canada
Paris, , France
Paris, , France
Berlin, , Germany
Guadalajara, , Mexico
Mexico City, , Mexico
Madrid, , Spain
Madrid, , Spain
Valencia, , Spain
Countries
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Other Identifiers
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WV16726
Identifier Type: -
Identifier Source: org_study_id