A Relative Bioavailability Study of Valcyte (Valganciclovir) in Lung Transplant Recipients With or Without Cystic Fibrosis.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00377741
First received: September 15, 2006
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This study will assess the relative bioavailability of ganciclovir from the pro- drug valganciclovir in lung transplant recipients with or without cystic fibrosi s. Each patient will receive 900mg valganciclovir daily for the period specified at their center, starting as soon as possible after the transplant. Pharmacokin etic assessments will be made provided that steady-state kinetics of ganciclovir and immunosuppressive drugs have been obtained (>=4 days of drug therapy). Bloo d samples for pharmacokinetic analysis will be taken up to 24h post-dose on one occasion. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Relative Bioavailability Study of Ganciclovir From the Pro-drug, Valganciclovir, in Lung Transplant Recipients With or Without Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • AUC and Cmax of ganciclovir. [ Time Frame: At steady state ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: December 2004
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: valganciclovir [Valcyte]
900mg po

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male or female patients, >=14 years of age;
  • first lung or heart-lung transplant recipient;
  • at risk of CMV disease (D+R-,D+R+ or D-R+);
  • estimated creatinine clearance >=60mL/min;
  • stable immunosuppressive and 900mg Valcyte dosing regimens (>=4 days) prior to pharmacokinetic assessments.

Exclusion Criteria:

  • history of any adverse reaction to acyclovir, valacyclovir, ganciclovir or valganciclovir;
  • evidence of graft rejection;
  • patient has received anti-CMV prophylaxis with a treatment other than cytogam, ganciclovir or valganciclovir between transplant and screening.
  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: NCT00377741

Locations
United States, California
Los Angeles, California, United States, 90033
United States, Colorado
Denver, Colorado, United States, 80262
United States, North Carolina
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15213
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: NCT00377741     History of Changes
Other Study ID Numbers: WP18046
Study First Received: September 15, 2006
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cystic Fibrosis
Cytomegalovirus Infections
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Pathologic Processes
Valganciclovir
Ganciclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014