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Trial record 14 of 7508 for:    Area Under Curve

Valganciclovir Dosing in Pediatric Solid Organ Transplant Recipients

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ClinicalTrials.gov Identifier: NCT02503982
Recruitment Status : Completed
First Posted : July 21, 2015
Results First Posted : June 30, 2016
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Infection in Solid Organ Transplant Recipients
Intervention Drug: prophylactic Valganciclovir
Enrollment 13
Recruitment Details conducted at the Schneider Children’s Medical Center (SCMC) from December 2014 to August 2015.
Pre-assignment Details A prospective pharmacokinetic. age <18 years of age, GFR>60 mL/min/1.73m2, solid-organ transplantation and oral VGC prophylaxis for CMV infection
Arm/Group Title Solid Organ Transplanted Children
Hide Arm/Group Description

Intervention: treatment with prophylactic oral valganciclovir with a fixed dose of 17 mg/kg once daily for prophylaxis. Max dose was 900 mg.

prophylactic Valganciclovir: The common practice dose at Schneider Children's Medical Center dosing guidelines of valganciclovir is 17 mg/kg once daily for prophylaxis. Max dose was 900 mg.

Period Title: Overall Study
Started 13
Completed 13
Not Completed 0
Arm/Group Title Solid Organ Transplanted Children
Hide Arm/Group Description

Intervention: treatment with prophylactic oral valganciclovir with a fixed dose of 17 mg/kg once daily for prophylaxis. Max dose was 900 mg.

prophylactic Valganciclovir: The common practice dose at Schneider Children's Medical Center dosing guidelines of valganciclovir is 17 mg/kg once daily for prophylaxis. Max dose was 900 mg.

Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
<=18 years
13
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 13 participants
7.3
(2.2 to 11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
4
  30.8%
Male
9
  69.2%
1.Primary Outcome
Title Area Under the Curve (AUC)
Hide Description Valganciclovir area under the curve (AUC) calculated with the trapezoidal method using drug levels measured at 2, 5 and 10 h, and extrapolated beyond the 10 hour time point to arrive at a 24-hour curve.
Time Frame drug levels measured at 2, 5 and 10 h following administration of the dose on day 4 creating a 24 hours curve
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Solid Organ Transplanted Children
Hide Arm/Group Description:

Intervention: treatment with prophylactic oral valganciclovir with a fixed dose of 17 mg/kg once daily for prophylaxis. Max dose was 900 mg.

prophylactic Valganciclovir: The common practice dose at Schneider Children's Medical Center dosing guidelines of valganciclovir is 17 mg/kg once daily for prophylaxis. Max dose was 900 mg.

Overall Number of Participants Analyzed 13
Median (Inter-Quartile Range)
Unit of Measure: mcg∙h/mL
21.0
(17.1 to 39.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Solid Organ Transplanted Children
Hide Arm/Group Description

Intervention: treatment with prophylactic oral valganciclovir with a fixed dose of 17 mg/kg once daily for prophylaxis. Max dose was 900 mg.

prophylactic Valganciclovir: The common practice dose at Schneider Children's Medical Center dosing guidelines of valganciclovir is 17 mg/kg once daily for prophylaxis. Max dose was 900 mg.

All-Cause Mortality
Solid Organ Transplanted Children
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Solid Organ Transplanted Children
Affected / at Risk (%) # Events
Total   3/13 (23.08%)    
Blood and lymphatic system disorders   
Hematologic toxicity  3/13 (23.08%)  3
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Solid Organ Transplanted Children
Affected / at Risk (%) # Events
Total   0/13 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Liat Ashkenazi-Hoffnung
Organization: Schneider Children's Medical Center of Israel
Phone: 972-3-9253681
EMail: LiatA3@clalit.org.il
Layout table for additonal information
Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02503982     History of Changes
Other Study ID Numbers: 001-14-RMC
First Submitted: July 14, 2015
First Posted: July 21, 2015
Results First Submitted: May 23, 2016
Results First Posted: June 30, 2016
Last Update Posted: April 4, 2017