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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01165580
First received: July 16, 2010
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

This open label study will assess the pharmacokinetics and the safety and tolera bility of Valcyte (valganciclovir) powder for oral solution in neonatal and infa nt heart transplant patients < 4 months of age.


Condition Intervention Phase
Cytomegalovirus Infections, Heart Transplantation
Drug: valganciclovir [Valcyte]
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Pharmacokinetics and Safety of Valganciclovir in Pediatric Heart Transplant Recipients < 4 Months of Age

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Area under plasma concentration versus time curve of ganciclovir [ Time Frame: 0, 1-3, 3-7, 7-12, 24 hours post-dose ] [ Designated as safety issue: No ]
  • Apparent volume of distribution of ganciclovir [ Time Frame: 0, 1-3, 3-7, 7-12, 24 hours post-dose ] [ Designated as safety issue: No ]
  • Terminal half-life of ganciclovir [ Time Frame: 0, 1-3, 3-7, 7-12, 24 hours post-dose ] [ Designated as safety issue: No ]
  • Peak concentration of ganciclovir [ Time Frame: 0, 1-3, 3-7, 7-12, 24 hours post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety (Incidence of adverse events) [ Time Frame: 9 days ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: May 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: valganciclovir [Valcyte]
oral dose, Days 1 and 2

  Eligibility

Ages Eligible for Study:   up to 124 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01165580

Locations
United States, California
Loma Linda, California, United States, 92354
Palo Alto, California, United States, 94304
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Georgia
Atlanta, Georgia, United States, 30322
United States, Michigan
Ann Arbor, Michigan, United States, 48109
Detroit, Michigan, United States, 48201
United States, Missouri
Saint Louis, Missouri, United States, 63110
United States, New York
Bronx, New York, United States, 10467
United States, North Carolina
Durham, North Carolina, United States, 22710
United States, Ohio
Cincinnati, Ohio, United States, 45229
Cleveland, Ohio, United States, 44195
United States, South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Nashville, Tennessee, United States, 37232-9119
United States, Texas
Dallas, Texas, United States, 75390
United States, Washington
Seattle, Washington, United States, 98105
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53226
Canada, Alberta
Edmonton, Alberta, Canada, T6G 1C9
Spain
Madrid, Spain, 28046
Madrid, Spain, 28007
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01165580     History of Changes
Other Study ID Numbers: NP22523, 2010-021172-28
Study First Received: July 16, 2010
Last Updated: November 3, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cytomegalovirus Infections
DNA Virus Infections
Herpesviridae Infections
Virus Diseases
Ganciclovir
Valganciclovir
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014