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

NCT ID: NCT00377741

Last Updated: 2015-12-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2006-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cytomegalovirus Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

valganciclovir [Valcyte]

Intervention Type DRUG

900mg po

Interventions

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valganciclovir [Valcyte]

900mg po

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Los Angeles, California, United States

Site Status

Denver, Colorado, United States

Site Status

Durham, North Carolina, United States

Site Status

Cleveland, Ohio, United States

Site Status

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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WP18046

Identifier Type: -

Identifier Source: org_study_id