YSPSL for Prevention of Delayed Graft Function in Cadaveric Liver Transplantation
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|ClinicalTrials.gov Identifier: NCT00450398|
Recruitment Status : Unknown
Verified January 2008 by Y's Therapeutics, Inc..
Recruitment status was: Active, not recruiting
First Posted : March 22, 2007
Last Update Posted : January 29, 2008
|Condition or disease||Intervention/treatment||Phase|
|Liver Diseases||Drug: YSPSL Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 :||March 2007|
|Actual Primary Completion Date :||December 2007|
|Estimated Study Completion Date :||February 2008|
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.
|Placebo Comparator: 2||
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
- Delayed graft function post transplant [ Time Frame: 6 months ]
- Liver function parameters through 6 months post transplant [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00450398
|United States, California|
|UCLA School of Medicine|
|Los Angeles, California, United States, 90095|
|Study Director:||Stefan Hemmerich, PhD||Y's Therapeutics, Inc.|