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 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT00166556
Eligibility Criteria:
Inclusion Criteria:
1. Male or female 18 years of age or older
2. Necessity for liver transplant
3. A negative pregnancy test at study entry for females of child-bearing potential
4. For participants with reproductive potential, agreement to use approved methods of birth control for the duration of their participation
5. Ability to provide informed consent
6. Availability of donor spleen
Exclusion Criteria:
1. Previous transplant
2. Multiorgan transplant
3. Living donor transplant.
4. Donor liver from a donor positive for antibody against hepatitis B core antigen
5. Donor liver from a donor positive for antibody against hepatitis C
6. Donor liver from a non-heart-beating donor
7. Liver failure due to autoimmune disease, such as autoimmune hepatitis, primary sclerosing cholangitis, and primary biliary cirrhosis
8. Hepatitis B infection as defined by the presence of HbSAg or active treatment for hepatitis B
9. Hepatitis C as defined by the presence of antibody against hepatitis C.
10. Stage III or higher hepatocellular cancer based on pretransplant imaging
11. History of malignancy except hepatocellular cancer, or adequately treated in situ cervical carcinoma, adequately treated basal or squamous cell carcinoma of skin, or other malignancy which is judged to have a 5-year risk of recurrence of \< 5%
12. Active systemic infection at the time of transplantation
13. Clinically significant chronic renal disease
14. Clinically significant cardiovascular or cerebrovascular disease
15. Infection with human immunodeficiency virus
16. Any investigational drug received within 6 weeks of study entry
17. Hypersensitivity to Campath-1H or tacrolimus
18. Unwillingness or inability to comply with study requirements (Immune Tolerance Network CONFIDENTIAL iv Protocol ITN024ST Immunosuppression with Campath-1H Version 3.0 June 28, 2005 and Tacrolimus in Liver Transplantation)
19. Inability to give appropriate informed consent (e.g., hepatic encephalopathy stage 2 or higher at time of screening consent)
20. Positive PPD without evidence of prior treatment or administration of BCG
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00166556
Study Brief:
Protocol Section:
NCT00166556