Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT01509404
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01509404
Study Brief:
Protocol Section:
NCT01509404