Liver DiseasesPhase 2NCT00450398
YSPSL for Prevention of Delayed Graft Function in Cadaveric Liver Transplantation
A Phase 2 study testing YSPSL in people with Liver Diseases, run by Y's Therapeutics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Diseases
- What is being tested?
- YSPSL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Feb 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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 an uncontrolled active infection (on antibiotics with controlled infection is not an exclusion) ;
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA School of Medicine
Los Angeles, California, 90095
About this study
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
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.
- Conditions
- Liver Diseases
- Being tested
- YSPSL, Placebo
- Keywords
- Delayed graft function
- Medical subject headings
- Liver Diseases, Delayed Graft Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YSPSLDrug
Also called rPSGL-Ig, recombinant P-selectin glycoprotein ligand-Ig
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.
PlaceboDrug
Also called Viaspan
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | YSPSL (rPSGL-Ig) Receives: Drug: YSPSL |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delayed graft function post transplant
Measured: 6 months
Secondary outcomes (1)
Liver function parameters through 6 months post transplant
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionDec 2007
- Study completionFeb 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Y's Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Stefan Hemmerich, PhD, Study director, Y's Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00450398
- Sponsor's protocol ID
- YSPSL-0002-PF
- Status last verified
- Jan 2008
- First submitted
- 20 Mar 2007
- Last updated
- 29 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00450398
- Acronym / sponsor ID
- YSPSL-0002-PF
- Conditions
- Liver Diseases
- Keywords
- Delayed graft function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Y's Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Feb 2008 (estimated)
- First posted
- 22 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: YSPSLYSPSL (rPSGL-Ig) |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (13 listed)
- 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 an uncontrolled active infection (on antibiotics with controlled infection is not an exclusion) ;
- Patient has active Hepatitis B virus (HBV)/transplant for HBV related cirrhosis;
- Patient has previously participated in this study or another study with YSPSL;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YSPSLAlso: rPSGL-Ig, recombinant P-selectin glycoprotein ligand-IgYSPSL 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. | Drug | 1 |
| PlaceboAlso: ViaspanEx 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. | Drug | 2 |
Primary outcome
Delayed graft function post transplant
Time frame: 6 months
1 secondary outcome
Liver function parameters through 6 months post transplant
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Hemmerich, PhD study director
Y's Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YSPSL in people with Liver Diseases, run by Y's Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delayed graft function post transplant (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2008.