A RANDOMIZED, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF PROPHYLACTIC USE OF MARIBAVIR VERSUS ORAL GANCICLOVIR FOR THE PREVENTION OF CYTOMEGALOVIRUS DISEASE IN RECIPIENTS OF ORTHOTOPIC LIVER TRANSPLANTS

Conditions: Main purpose is to assess the efficacy and safety of prophylactic use of oral Maribavir versus oral Ganciclovir to prevent cytomegalovirus disease in recipients of orthotopic liver transplants at high risk of developing CMV disease.
MedDRA version: 9.1Level: LLTClassification code 10009701Term: CMV

Registration Number: EUCTR2007-004729-16-GB

Lead Sponsor: ViroPharma Incorporated

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 348

Inclusion Criteria

Subjects must:
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

Subjects must not:
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. Have estimated creatinine clearance <10 mL/min or require dialysis at time of
enrollment.
7. 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.
8. Require mechanical ventilation or vasopressors for hemodynamic support at time
of enrollment.
9. Be pregnant (as determined by ß-hCG testing prior to initiation of study drug) or
breastfeeding.
10. Have received any investigational antiviral agent or investigational
immunosuppressant agent within 30 days before the initiation of study drug.
11. Have received maribavir in a previous clinical trial.
12. 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.