A Study on the Pharmacokinetics and Safety of Valcyte (Valganciclovir) in Pediatric Heart Transplant Recipients Less Than 4 Months of Age
NCT ID: NCT01165580
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
17 participants
INTERVENTIONAL
2011-05-31
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Single Arm
valganciclovir [Valcyte]
oral dose, Days 1 and 2
Interventions
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valganciclovir [Valcyte]
oral dose, Days 1 and 2
Eligibility Criteria
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Inclusion Criteria
* Parent or guardian of the patient is willing and able to give written informed consent
* Patient has received a first heart transplant
* Patient is at risk of developing cytomegalovirus (CMV) disease and is being treated with i.v. ganciclovir or oral valganciclovir for prevention of CMV
* Adequate hematological and renal function
* Able to tolerate oral medication (any appropriate form of tube feeding is acceptable)
Exclusion Criteria
* Severe, uncontrolled, clinically abnormal diarrhea
* Liver enzyme elevation of more than five times the upper limit of normal for AST (SGOT) or ALT (SGPT)
* Patient requires use of any protocol prohibited concomitant medications
* Patient has previously participated in this clinical trial
124 Days
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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Loma Linda, California, United States
Palo Alto, California, United States
Aurora, Colorado, United States
Atlanta, Georgia, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
St Louis, Missouri, United States
The Bronx, New York, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Charleston, South Carolina, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Seattle, Washington, United States
Milwaukee, Wisconsin, United States
Edmonton, Alberta, Canada
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Countries
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Other Identifiers
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2010-021172-28
Identifier Type: -
Identifier Source: secondary_id
NP22523
Identifier Type: -
Identifier Source: org_study_id