Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for Cytomegalovirus Infection
Condition: Cytomegalovirus Disease
MeSH terms: Cytomegalovirus Infections
Intervention: Valganciclovir; CMV hyperimmune globulin; Valganciclovir
Intervention description: Valcyte per package insert guidelines for 200 days post transplant; 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant; valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant
Intervention MeSH terms: Valganciclovir
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CMV; cytomegalovirus; transplant

Summary:

      The purpose of the study is to assess the incidence and severity of late Cytomegalovirus
      (CMV) disease, defined as CMV syndrome or tissue invasive disease occurring between 100 and
      200 days and after 200 days post-transplant in patients treated with valganciclovir per
      package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant
      versus valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam
      100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female patients ≥ 18 years of age.

          2. Male or female patients who CMV seronegative receiving a kidney, pancreas or liver
             from a seropositive donor.

          3. 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.

          4. The patient has given written informed consent to participate in the study.

        Exclusion Criteria:

          1. Solid organ transplant recipient is CMV seropositive at the time of transplant.

          2. Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV).

          3. Patient has uncontrolled concomitant infection or any other unstable medical condition
             that could interfere with the study objectives.

          4. 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.

          5. Patient is taking or has been taking an investigational drug in the 30 days prior to
             transplant.

          6. Patient has a known hypersensitivity to valganciclovir, tacrolimus, mycophenolate
             mofetil, rabbit anti-thymocyte globulin, CMV hyperimmune globulin, basiliximab or
             corticosteroids.

          7. Patients with severe diarrhea or other gastrointestinal disorders that might interfere
             with their ability to absorb oral medication.

          8. 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.

          9. 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.

         10. Inability to cooperate or communicate with the investigator.