Status:
COMPLETED
Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for Cytomegalovirus Infection
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
CSL Behring
Conditions:
Cytomegalovirus Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01509404
Start Date
November 1 2011
End Date
December 1 2015
Last Update
October 4 2018
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425