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Status unknownNCT00450398Updated Jan 29, 2008

YSPSL for Prevention of Delayed Graft Function in Cadaveric Liver Transplantation

A Phase 2 interventional study of YSPSL and Placebo in Liver Diseases, sponsored by Y's Therapeutics, Inc.. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-01-29.

Sponsored by Y's Therapeutics, Inc. · Phase 2, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jan 2008), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

This will be a single-center, single-dose study. The study will be a randomized, double-blind, placebo-controlled, single-dose study. Patients who are undergoing cadaveric orthotopic liver transplantation and are at risk for development of DGF, based upon known risk factors, will be eligible to participate in the study. 12 patients will be enrolled in the study.

02

Conditions studied

  • Liver Diseases

Keywords

  • Delayed graft function
03

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's planned enrollment of 12 is below the median of 50 across 1,323 interventional studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Y's Therapeutics, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patient will be a recipient of a primary (first) ABO compatible cadaveric liver allograft;
  2. Patient's age is >=18 years;
  3. Patient is not a recipient of a multivisceral transplant or simultaneous kidney transplant;
  4. Patient has not undergone prior organ or cellular transplant of any type;
  5. Patient has a Model for End Stage Liver Disease (MELD) score of \<28;
  6. Cold ischemia time (CIT) anticipated to be less than 12 hours;
  7. Donor liver procured by UCLA liver team;
  8. 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);
  9. For patients who are women of childbearing potential, patient has a negative pregnancy test (either urine or serum) within 48 hours prior to transplant;
  10. Patient (male and female) is willing to use an acceptable form of birth control for at least 3 months post-treatment; and
  11. Patient is willing and able to sign informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Patient has a prior organ transplant of any type;
  2. Patient has known allergic or intolerance reactions to human immune globulins, antibodies, or components of the formulation or known contraindication to administration of YSPSL;
  3. Patient has an uncontrolled active infection (on antibiotics with controlled infection is not an exclusion) ;
  4. Patient has active Hepatitis B virus (HBV)/transplant for HBV related cirrhosis;
  5. Patient has previously participated in this study or another study with YSPSL;
  6. Patient has received investigational therapy within 90 days prior to the transplant procedure;
  7. 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);
  8. 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;
  9. Patient is planned to receive a living donor liver transplant;
  10. Patient lives >200 miles away or otherwise is not able to participate in study follow-up visits;
  11. Donor body mass index >28;
  12. Donor liver biopsy >20% macrosteototic fat;
  13. Donor age >65.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    1

    YSPSL (rPSGL-Ig)

    Drug: YSPSL

  • Placebo comparator
    2

    Drug: Placebo

Interventions

  • DrugYSPSL

    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

  • DrugPlacebo

    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

06

What researchers measure

Primary outcomes

  1. Delayed graft function post transplant

    Time frame: 6 months

Secondary outcomes

  1. Liver function parameters through 6 months post transplant

    Time frame: 6 months

07

Study locations

1 site
  • UCLA School of Medicine
    Los Angeles, California 90095, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00450398
Lead sponsor
Y's Therapeutics, Inc.
First posted
Mar 22, 2007
Start date
Mar 2007
Primary completion
Dec 2007
Completion
Feb 2008 (estimated)
Last update
Jan 29, 2008

Study contacts

Stefan Hemmerich, PhD
study director · Y's Therapeutics, Inc.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.

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