A randomised, double-blind study to assess the efficacy and safety of prophylactis use of maribavir versus oral ganciclovir for the prevention of cytomegalovirus disease in recipients of orthotopic liver transplants - ND

VIROPHARMA INCORPORATED0 sites348 target enrollmentJanuary 9, 2008

Overview

No summary available.

Registry

who.int

Start Date

January 9, 2008

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Be informed of the nature of the study and provide written informed consent before any study\-specific procedures are performed.
•2\. Be ≥ 18 years of age.
•3\. Weigh ≥ 40 kg.
•4\. Be undergoing their first orthotopic liver transplantation (the transplanted graft may
•be a deceased\-donor whole organ, a deceased\-donor split\-liver graft, or live\-donor graft).
•5\. Have negative pre\-transplantation CMV serology and receive a liver from a donor with positive pre\-transplantation CMV serology (i.e., donor positive / recipient negative \[D\+ R?]).
•6\. Have no detectable CMV infection post\-transplant. This must be documented by CMV testing of blood using either CMV pp65 antigenemia assay, CMV DNA PCR,or other CMV DNA detection assay from a sample collected post\-transplant. Results
•from either the central laboratory or a local laboratory can be used for qualification.
•7\. Have the following findings as part of screening laboratory assessments (results from either the central laboratory or a local laboratory can be used for qualification: Absolute neutrophil count (ANC) ≥500/mm3 \[0\.5 x 109/L; Platelet count ≥25,000/mm3 \[25 x 109/L]
•8\. Be randomized such that dosing with study drug can begin within 10 days posttransplant.

•1\. Be undergoing multi\-organ transplantation or have undergone prior organ transplantation (except skin, hair, or cornea).
•2\. Have known human immunodeficiency virus (HIV) infection (based on testing
•performed during the transplant evaluation process or during screening for this study).
•3\. Have CMV\-related organ disease within 6 months prior to the day of enrollment.
•4\. Be receiving any of the following therapies at the time of enrollment: ganciclovir, valganciclovir, foscarnet, cidofovir, acyclovir (\>25 mg/kg IV per day, valacyclovir (\>3 g p.o. per day, famciclovir (\>1500 mg p.o. per day)NOTE: A subject may have received any of the above listed drugs prior to enrollment. If this is the case, these drugs must be discontinued by the time of enrollment; no minimum ?washout? period is required before commencement of dosing with study drugs.
•5\. Have received cytomegalovirus immune globulin within 30 days prior to the day of enrollment.
•6\. Be receiving therapy with phenytoin at the time of enrollment.
•7\. Have estimated creatinine clearance \<10 mL/min or require dialysis at time of enrollment.
•8\. Have severe vomiting, diarrhea or other severe gastrointestinal illness within 24 hours prior to the time of enrollment that would preclude administration of oral medication.
•9\. Require mechanical ventilation or vasopressors for hemodynamic support at time of enrollment.