YSPSL for Prevention of Delayed Graft Function in Cadaveric Liver Transplantation

NCT00450398 | Unknown Phase 2 DMC

• 1 other identifier: YSPSL-0002-PF
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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 directly ex vivo via the portal vein and to the recipient intravenously prior to reperfusion. Recently, P-selectin expression has been associated in liver grafts with prolonged cold storage times and rejection. By examining biomarkers of IRI including P-selectin by immunohistochemistry and/or quantitative PCR, liver histology and hepatic blood flow using established techniques, the goal of this study is to evaluate the feasibility of using these modalities for future studies of safety and efficacy.

Conditions

Liver Diseases

Keywords

Delayed graft function

Outcome Measures

Primary Outcomes (1)

• Delayed graft function post transplant

  6 months

Secondary Outcomes (1)

• Liver function parameters through 6 months post transplant

  6 months

Study Arms (2)

1

EXPERIMENTAL

YSPSL (rPSGL-Ig)

Drug: YSPSL

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

YSPSL DRUG

YSPSL administered as an ex vivo flush (20 mg YSPSL in Viaspan® 200 mL total volume) into the portal vein prior to transplant at the back table; YSPSL 1 mg/kg administered IV to the transplant recipient prior to arterial reperfusion of the liver.

Also known as: rPSGL-Ig, recombinant P-selectin glycoprotein ligand-Ig

1

Placebo DRUG

Ex vivo flush of placebo control (200 mL Viaspan®) into the portal vein prior to transplant and 0.1 mL/kg placebo control (saline) IV to the transplant recipient prior to arterial reperfusion of the liver.

Also known as: Viaspan

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient will be a recipient of a primary (first) ABO compatible cadaveric liver allograft;
• Patient's age is \>=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 \<28;
• Cold ischemia time (CIT) anticipated to be less than 12 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; and
• Patient is willing and able to sign informed consent.

You may not qualify if:

• 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 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 \>28;
• Donor liver biopsy \>20% macrosteototic fat;
• Donor age \>65.

Sponsors & Collaborators

• Y's Therapeutics, Inc.: lead

Study Sites (1)

UCLA School of Medicine

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Liver Diseases; Delayed Graft Function

Interventions

University of Wisconsin-lactobionate solution

Condition Hierarchy (Ancestors)

Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefan Hemmerich, PhD

  Y's Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 20, 2007
• First Posted: March 22, 2007
• Study Start: March 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: February 1, 2008
• Last Updated: January 29, 2008

Record last verified: 2008-01

Locations

US (1)