YSPSL for Prevention of Ischemic Reperfusion Injury in Patients Undergoing Cadaveric Orthotopic Liver Transplantation (YSPSL)
|ClinicalTrials.gov Identifier: NCT00876902|
Recruitment Status : Unknown
Verified April 2009 by Y's Therapeutics, Inc..
Recruitment status was: Active, not recruiting
First Posted : April 7, 2009
Last Update Posted : April 7, 2009
|Condition or disease||Intervention/treatment||Phase|
|Ischemia Reperfusion Injury||Drug: recombinant P-selectin glycoprotein ligand Ig fusion protein Drug: Viaspan® and saline||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||March 2009|
|Estimated Study Completion Date :||October 2009|
Active Group: (18 subjects) 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. One extra IV dose of 1 mg/kg will be given at the end of the procedure only to patients that have experienced an intraoperative blood loss of greater than 10 units.
Drug: recombinant P-selectin glycoprotein ligand Ig fusion protein
The active study drug dose includes both a 1 mg/kg IV infusion for the recipient and a 20 mg [approximately 0.27 mg/kg] as an ex vivo flush. The doses will be administered via 2 separate infusions of study agent: one 20 mg dose into the portal vein of the liver prior to implantation as an ex vivo flush with Viaspan®; and the second infusion of 1 mg/kg intravenously into the recipient, when technically feasible, prior to the hepatic artery anastomosis. Those patients that experience an intraoperative blood loss of >10 units, will receive an additional 1 mg/kg IV infusion of study agent at the end of the transplant surgery.
Placebo Comparator: 2
Placebo Control: (18 subjects) 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. One additional infusion of 0.1 mL/kg placebo control (saline) will be given at the end of the procedure to patients that have experienced an intraoperative blood loss of greater than 10 units.
Drug: Viaspan® and saline
Placebo of a volume equivalent to active study drug will be prepared for administration to the control group to help maintain the blind. Those patients that experience an intraoperative blood loss of >10 units, will receive an additional 1 mg/kg IV infusion of placebo equivalent at the end of the transplant surgery.
Other Name: Placebo
- Safety will be evaluated by clinical and laboratory assessments, an abbreviated pharmacokinetic (PK) profile of the administered dose of YSPSL, and graft function and patient and graft survival through 6 months post-transplant. [ Time Frame: 6 months post trasplant ]
- To evaluate the potential efficacy of prophylaxis with YSPSL on ischemia reperfusion injury (IRI) as assessed by proposed efficacy evaluations of IRI in liver transplants, in patients who meet eligibility criteria for the trial. [ Time Frame: 6 months post transplant ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00876902
|United States, California|
|UCLA School of Medicine|
|Los Angeles, California, United States, 90095|
|Study Director:||Stefan Hemmerich, PhD||Y's Therapeutics, Inc.|