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:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT00876902
Eligibility Criteria:
Inclusion Criteria:
* Patient will be a recipient of a primary (first) ABO compatible cadaveric liver allograft
* Patient's age is less than 18 years
* Patient is not a recipient of a multivisceral transplant or simultaneous kidney transplant
* Patient has not undergone prior organ or cellular transplant of any type
* Patient has a Model for End Stage Liver Disease (MELD) score of ≤38
* Cold ischemia time (CIT) anticipated to be less than 14 hours
* Donor liver procured by UCLA liver team
* Veno-veno bypass is not planned to be used for the patient (e.g. no prior surgery or other factor that indicates a risk for excessive blood loss and therefore a need for veno-veno bypass +/- autologous recovery during surgery)
* For patients who are women of childbearing potential, patient has a negative pregnancy test (either urine or serum) within 48 hours prior to transplant
* Patient (male and female) is willing to use an acceptable form of birth control for at least 3 months post-treatment
* Patient is willing and able to sign informed consent.
Exclusion Criteria:
* Patient has a prior organ transplant of any type
* Patient has known allergic or intolerance reactions to human immune globulins, antibodies, or components of the formulation or known contraindication to administration of YSPSL
* Patient has an uncontrolled active infection (on antibiotics with controlled infection is not an exclusion)
* Patient has active Hepatitis B virus (HBV)/transplant for HBV related cirrhosis
* Patient has previously participated in this study or another study with YSPSL
* Patient has received investigational therapy within 90 days prior to the transplant procedure
* Patient has current drug or alcohol abuse or, in the opinion of the investigator, is at risk for poor compliance with the visits in this protocol (no drug testing required)
* Patient is a pregnant or nursing female, a female of childbearing potential planning to become pregnant within the duration of this study, or is not practicing birth control
* Patient is planned to receive a living donor liver transplant
* Patient lives \>200 miles away or otherwise is not able to participate in study follow-up visits
* Donor body mass index \>40
* Donor liver biopsy \>40% macrosteatotic fat
* Donor age \>70.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00876902
Study Brief:
Protocol Section:
NCT00876902