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

• Conditions: Patient undergone to orthotopic liver transplants; MedDRA version: 9.1Level: LLTClassification code 10011831Term: Cytomegalovirus infection

• Registration Number: EUCTR2007-004729-16-IT
• Lead Sponsor: VIROPHARMA INCORPORATED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 348

Inclusion Criteria

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.
9. If female, be either postmenopausal, surgically sterile, or have a negative serum pregnancy test as part of screening laboratory assessments. Women of child bearing
potential also must agree to use an acceptable method of birth control (e.g., abstinence, IUD, or barrier method), as determined by the investigator, during the study drug administration period and for 3 months afterward. Hormonal contraceptives should not be used as the sole method of birth control. If male, must agree to use an acceptable method of birth control (e.g., abstinence or
barrier method), as determined by the investigator, during the study drug
administration period and for 3 months afterward.
10. Be able to swallow tablets and capsules
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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.
10. Be pregnant (as determined by β-hCG testing prior to initiation of study drug) or breastfeeding.
11. Have received any investigational antiviral agent or investigational
immunosuppressant agent within 30 days before the initiation of study drug.
12. Have received maribavir in a previous clinical trial.
13. Have any clinically significant medical or surgical condition (other than the underlying reason for transplantation) that in the investigator?s or sponsor?s
opinion would compromise the outcome of the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy of the<br>prophylactic use of maribavir versus oral ganciclovir when administered for up to 14 weeks for the prevention of cytomegalovirus disease in recipients of orthotopic liver transplants at<br>high risk of developing CMV disease;Secondary Objective: To compare the safety and tolerability of the<br>prophylactic use of maribavir versus oral ganciclovir when administered for up to 14 weeks in this subject population;Primary end point(s): The primary efficacy endpoint is the incidence of CMV disease<br>(either symptomatic CMV infection or CMV organ disease, as adjudicated by an independent<br>Endpoint Committee) within 6 months post-transplant.