Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for Cytomegalovirus Infection

Inclusion criteria

• Male and female patients ≥ 18 years of age.
• Male or female patients who CMV seronegative receiving a kidney, pancreas or liver from a seropositive donor.
• Female patients of child bearing potential must have a negative urine or serum pregnancy test within the past 48 hours prior to receiving transplant or study inclusion.
• The patient has given written informed consent to participate in the study.

Exclusion criteria

• Solid organ transplant recipient is CMV seropositive at the time of transplant.
• Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV).
• Patient has uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives.
• Patients with thrombocytopenia (<25,000/mm3 ), with an absolute neutrophil count of < 1,000/mm3); and/or leucopoenia (< 2,000/mm3), or anemia (hemoglobin < 6 g/dL) prior to study inclusion.
• Patient is taking or has been taking an investigational drug in the 30 days prior to transplant.
• Patient has a known hypersensitivity to valganciclovir, tacrolimus, mycophenolate mofetil, rabbit anti-thymocyte globulin, CMV hyperimmune globulin, basiliximab or corticosteroids.
• Patients with severe diarrhea or other gastrointestinal disorders that might interfere with their ability to absorb oral medication.
• Patient is pregnant or lactating, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by positive human Chorionic Gonadotropin (hCG) laboratory test.
• Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator.
• Inability to cooperate or communicate with the investigator.