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A Study on the Pharmacokinetics and Safety of Valcyte (Valganciclovir) in Pediatric Heart Transplant Recipients Less Than 4 Months of Age

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01165580
Recruitment Status : Completed
First Posted : July 20, 2010
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE July 16, 2010
First Posted Date  ICMJE July 20, 2010
Last Update Posted Date November 2, 2016
Study Start Date  ICMJE May 2011
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2010)
  • Area under plasma concentration versus time curve of ganciclovir [ Time Frame: 0, 1-3, 3-7, 7-12, 24 hours post-dose ]
  • Apparent volume of distribution of ganciclovir [ Time Frame: 0, 1-3, 3-7, 7-12, 24 hours post-dose ]
  • Terminal half-life of ganciclovir [ Time Frame: 0, 1-3, 3-7, 7-12, 24 hours post-dose ]
  • Peak concentration of ganciclovir [ Time Frame: 0, 1-3, 3-7, 7-12, 24 hours post-dose ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 16, 2010)
Pharmacokinetics of ganciclovir following administration of oral valganciclovir: AUC, V, T1/2, C max [ Time Frame: Day 2: multiple sampling pre- and postdose ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2010)
Safety (Incidence of adverse events) [ Time Frame: 9 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2010)
Safety and tolerability: Adverse events, laboratory parameters [ Time Frame: from baseline to Day 9 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study on the Pharmacokinetics and Safety of Valcyte (Valganciclovir) in Pediatric Heart Transplant Recipients Less Than 4 Months of Age
Official Title  ICMJE Pharmacokinetics and Safety of Valganciclovir in Pediatric Heart Transplant Recipients < 4 Months of Age
Brief Summary This open label study will assess the pharmacokinetics and the safety and tolerability of Valcyte (valganciclovir) powder for oral solution in neonatal and infant heart transplant patients < 4 months of age.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Cytomegalovirus Infections, Heart Transplantation
Intervention  ICMJE Drug: valganciclovir [Valcyte]
oral dose, Days 1 and 2
Study Arms  ICMJE Experimental: Single Arm
Intervention: Drug: valganciclovir [Valcyte]
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 13, 2014)
17
Original Estimated Enrollment  ICMJE
 (submitted: July 16, 2010)
16
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males and females, 0 to < 4 months (< 125 days) of age at the time of the last PK assessment in this study
  • 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:

  • Allergic or significant adverse reaction to acyclovir, valacyclovir or ganciclovir in the past
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 124 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01165580
Other Study ID Numbers  ICMJE NP22523
2010-021172-28
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP