YSPSL for Prevention of Delayed Graft Function in Cadaveric Liver Transplantation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by Y's Therapeutics, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Y's Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00450398
First received: March 20, 2007
Last updated: January 24, 2008
Last verified: January 2008
  Purpose

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.


Condition Intervention Phase
Liver Diseases
Drug: YSPSL
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Controlled, Prospective, Blinded, Randomized, Single-Center, Study of YSPSL for Prevention of Ischemic Reperfusion Injury in Patients Undergoing Cadaveric Orthotopic Liver Transplantation

Resource links provided by NLM:


Further study details as provided by Y's Therapeutics, Inc.:

Primary Outcome Measures:
  • Delayed graft function post transplant [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Liver function parameters through 6 months post transplant [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: March 2007
Estimated Study Completion Date: February 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
YSPSL (rPSGL-Ig)
Drug: YSPSL
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.
Other Names:
  • rPSGL-Ig
  • recombinant P-selectin glycoprotein ligand-Ig
Placebo Comparator: 2 Drug: Placebo
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.
Other Name: Viaspan

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00450398

Locations
United States, California
UCLA School of Medicine
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Y's Therapeutics, Inc.
Investigators
Study Director: Stefan Hemmerich, PhD Y's Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Stefan Hemmerich, PhD, RAC, Y's Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00450398     History of Changes
Other Study ID Numbers: YSPSL-0002-PF
Study First Received: March 20, 2007
Last Updated: January 24, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Y's Therapeutics, Inc.:
Delayed graft function

Additional relevant MeSH terms:
Liver Diseases
Reperfusion Injury
Delayed Graft Function
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014