Phase 1
Completed N=31
A Relative Bioavailability Study of Valcyte (Valganciclovir) in Lung Transplant Recipients With or Without Cystic Fibrosis.
Cytomegalovirus Infections
Source: ClinicalTrials.gov NCT00377741 ↗
Enrolled (actual)
31
Serious AEs
12.5%
Results posted
Dec 2015
Primary outcomePrimary: Area Under The Observed Plasma Concentration-Time Curve Between Dosing Intervals AUC(0-tau) — 66.2; 54.1 h*mcg/mL
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under The Observed Plasma Concentration-Time Curve Between Dosing Intervals AUC(0-tau) |
66.2; 54.1 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Ganciclovir |
8.46; 7.54 | — |
| SECONDARY Time to Maximum Observed Plasma Concentration (Tmax) of Ganciclovir |
1.99; 1.98 | — |
| SECONDARY Apparent Elimination Rate (Kelim) of Ganciclovir |
4.43; 4.91 | — |
| SECONDARY Plasma Half-Life (T1/2) of Ganciclovir |
4.43; 4.91 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00377741). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.