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: November 26, 2015
Last verified: November 2015
  Purpose
This study will assess the relative bioavailability of ganciclovir from the pro-drug valganciclovir in lung transplant recipients with or without cystic fibrosis. Each patient will receive 900mg valganciclovir daily for the period specified at their center, starting as soon as possible after the transplant. Pharmacokinetic assessments will be made provided that steady-state kinetics of ganciclovir and immunosuppressive drugs have been obtained (>=4 days of drug therapy). Blood 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:
  • Area Under The Observed Plasma Concentration-Time Curve Between Dosing Intervals AUC(0-tau) [ Time Frame: Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post-dose ] [ Designated as safety issue: No ]
    The area under the plasma concentration-time curve from time zero to end of dosing interval (AUC [0-tau]) is a measure of the plasma ganciclovir concentration from time zero to end of dosing interval. It was computed using the linear trapezoidal rule. The pharmacokinetic parameters of valganciclovir were measured in plasma of all participants following a single oral dose valganciclovir at 900 mg on Day 1.

  • Maximum Observed Plasma Concentration (Cmax) of Ganciclovir [ Time Frame: Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post-dose ] [ Designated as safety issue: No ]
    The Cmax is defined as maximum observed Ganciclovir concentration. Cmax of valganciclovir were measured in plasma of all participants following a single tablet dose Valganciclovir at 900 mg at start of treatment on Day 1.


Secondary Outcome Measures:
  • Time to Maximum Observed Plasma Concentration (Tmax) of Ganciclovir [ Time Frame: Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post-dose ] [ Designated as safety issue: No ]
    The Tmax is defined as time to reach maximum observed Ganciclovir concentration. The pharmacokinetic parameters of Valganciclovir were measured in plasma of all participants following a single tablet dose Valganciclovir at 900 mg at start of treatment on Day 1.

  • Apparent Elimination Rate (Kelim) of Ganciclovir [ Time Frame: Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post-dose ] [ Designated as safety issue: No ]
    The apparent elimination rate is equal to the magnitude of the slope from the log-linear regression of plasma concentration versus time over the interval t to 24, where t is the first time-point used for this regression. Kelim was not reported for those participants for whom R-squared (adjusted) was lower than 0.70.

  • Plasma Half-Life (T1/2) of Ganciclovir [ Time Frame: Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12 and 24 hours post-dose ] [ Designated as safety issue: No ]
    Plasma half-life is the time measured for the plasma concentration to decrease by one half. The pharmacokinetic parameters of Valganciclovir were measured in plasma of all participants following a single tablet dose Valganciclovir at 900 mg at start of treatment on Day 1. T1/2 was not reported for those participants for whom R-squared (adjusted) was lower than 0.70.


Enrollment: 31
Study Start Date: December 2004
Study Completion Date: June 2006
Primary Completion Date: June 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
Results First Received: November 26, 2015
Last Updated: November 26, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on February 07, 2016