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A Study of Valcyte (Valganciclovir) Syrup Formulation in Pediatric Solid Organ Transplant Recipients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00090766
First received: September 3, 2004
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

This study will assess the safety and pharmacokinetics of Valcyte syrup in pedia tric solid organ transplant recipients. The anticipated time on study treatment is 3-12 months and the target sample size is less than 100 individuals.


Condition Intervention Phase
Cytomegalovirus Infections
Drug: valganciclovir [Valcyte]
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Study of the Safety and Pharmacokinetics of Valcyte Syrup in Pediatric Solid Organ Transplant Patients

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Adverse events, opportunistic infections, dose reductions, interruptions, or discontinuations because of adverse events, adverse changes in hematology and serum chemistry values\n\n [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic parameters; incidence of CMV viremia and disease\n [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: May 2004
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: valganciclovir [Valcyte]
po daily (dose based on body surface area and CrCL)

  Eligibility

Ages Eligible for Study:   3 Months to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients between 3 months and 16 years of age;
  • 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 have previously participated in this study;
  • 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.
  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: NCT00090766

  Show 21 Study Locations
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: NCT00090766     History of Changes
Other Study ID Numbers: WV16726
Study First Received: September 3, 2004
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
Valganciclovir
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014