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 @ 10:16 PM
Ignite Modification Date:
2025-12-24 @ 10:16 PM
NCT ID:
NCT00105235
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of nonimmune, nonviral, end-stage liver disease
* Need liver transplant
* Willing to use acceptable means of contraception for the duration of the study
Exclusion Criteria:
* Previous transplant
* Multiorgan transplant or living donor transplant
* Donor liver from a donor positive for antibody against hepatitis B core antigen or hepatitis C virus
* Donor liver from a non-heart-beating donor
* Liver failure due to autoimmune disease, such as autoimmune hepatitis, primary sclerosing cholangitis, or primary biliary cirrhosis
* Hepatitis B or C virus infection
* HIV infection
* Stage III or higher hepatocellular cancer based on pre-transplant imaging
* History of cancer. Patients with hepatocellular cancer, adequately treated in situ cervical carcinoma, or adequately treated basal or squamous cell carcinoma of skin are not excluded.
* Active systemic infection at the time of transplantation
* Clinically significant chronic renal, cardiovascular, or cerebrovascular disease
* Any investigational drug within 6 weeks of study entry
* Hypersensitivity to alemtuzumab or tacrolimus
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00105235
Study Brief:
Protocol Section:
NCT00105235