A Relative Bioavailability Study of Valcyte (Valganciclovir) in Lung Transplant Recipients With or Without Cystic Fibrosis.
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ClinicalTrials.gov Identifier: NCT00377741 |
Recruitment Status :
Completed
First Posted : September 18, 2006
Results First Posted : December 31, 2015
Last Update Posted : December 31, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cytomegalovirus Infections | Drug: valganciclovir [Valcyte] | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 31 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | December 2004 |
Actual Primary Completion Date : | June 2006 |
Actual Study Completion Date : | June 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Drug: valganciclovir [Valcyte]
900mg po |
- 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 ]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 ]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.
- 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 ]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 ]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 ]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.

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Ages Eligible for Study: | 14 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00377741
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 |
Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00377741 |
Other Study ID Numbers: |
WP18046 |
First Posted: | September 18, 2006 Key Record Dates |
Results First Posted: | December 31, 2015 |
Last Update Posted: | December 31, 2015 |
Last Verified: | November 2015 |
Cytomegalovirus Infections Cystic Fibrosis Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn |
Infant, Newborn, Diseases Herpesviridae Infections DNA Virus Infections Virus Diseases Valganciclovir Antiviral Agents Anti-Infective Agents |