Status:
UNKNOWN
YSPSL for Prevention of Ischemic Reperfusion Injury in Patients Undergoing Cadaveric Orthotopic Liver Transplantation
Lead Sponsor:
Y's Therapeutics, Inc.
Conditions:
Ischemia Reperfusion Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The study is designed to assess the feasibility of evaluating YSPSL for the amelioration of ischemia reperfusion injury following liver transplantation by administering YSPSL into the liver graft dire...
Detailed Description
YSPSL-0003 is an extension into 36 patients of the previous 12 patient pilot study YSPSL-0002 under an almost identical study protocol with extended inclusion criteria. Like YSPSL-0002, YSPSL-0003 is ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00876902
Start Date
May 1 2008
End Date
October 1 2009
Last Update
April 7 2009
Active Locations (1)
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1
UCLA School of Medicine
Los Angeles, California, United States, 90095