<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03031470</url>
  </required_header>
  <id_info>
    <org_study_id>TPL-RPX-01</org_study_id>
    <nct_id>NCT03031470</nct_id>
  </id_info>
  <brief_title>Pilot Study of Reparixin for Early Allograft Dysfunction Prevention in Liver Transplantation</brief_title>
  <official_title>A Multicenter, Open-label, Randomized Pilot Clinical Study of Efficacy and Safety of Reparixin for Prevention of Early Allograft Dysfunction in Patients Undergoing Orthotopic Liver Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dompé Farmaceutici S.p.A</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dompé Farmaceutici S.p.A</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Liver transplantation is currently the treatment of choice for end-stage liver cirrhosis of&#xD;
      different origin, as well as for a number of inborn metabolism disorders and liver tumors.&#xD;
      The need to perform a liver transplantation is high and amounts to 10 - 20 patients per 1&#xD;
      million population per year.&#xD;
&#xD;
      Experimental and clinical evidence demonstrate the harmful short and long-term effects of&#xD;
      ischemia-reperfusion injury (IRI) of the donor organ on the outcome of the intervention&#xD;
      performed. Severe manifestations of IRI of the liver transplant (LT) is one of the main&#xD;
      reasons for the increased length of hospitalization, the high cost of treating patients&#xD;
      during the post- surgery period, the development of persistent early allograft dysfunction or&#xD;
      loss, frequent crises of acute rejection, acute renal and multiple organ failure, and&#xD;
      mortality of the operated patients.&#xD;
&#xD;
      This pilot clinical study is designed to evaluate the efficacy and safety of Reparixin, which&#xD;
      is a new, potent and specific inhibitor of chemokine CXCL8 (Interleukin-8), as an agent to&#xD;
      prevent early allograft dysfunction caused by ischemia-reperfusion injury in patients&#xD;
      undergoing orthotopic liver transplantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Liver transplantation is currently the treatment of choice for end-stage liver cirrhosis of&#xD;
      different origin, as well as for a number of inborn metabolism disorders and liver tumors.&#xD;
      The need to perform a liver transplantation is high and amounts to 10 - 20 patients per 1&#xD;
      million population per year. The indication for liver transplantation is the presence of&#xD;
      irreversible liver disease with estimated life expectancy of less than 12 months, absence of&#xD;
      another treatment, presence of chronic liver disease, significantly reducing the patient's&#xD;
      quality of life and ability to work, as well as progressive liver disease with a life&#xD;
      expectancy less than in the case of liver transplantation (after liver transplantation 85% of&#xD;
      patients survive for 1 year and 70% - for 5 years).&#xD;
&#xD;
      Currently, about 200 liver transplantations are performed annually in Russia, which is more&#xD;
      than 10 times lower than the existing need and is far below the number of similar operations&#xD;
      performed abroad.&#xD;
&#xD;
      The vast majority of liver transplants for adult recipients are performed using liver&#xD;
      allografts from cadaveric donors. The rigorous list of requirements for a transplant&#xD;
      restricts significantly the use of cadaveric liver. Thus, the need to expand the pool of&#xD;
      donor organs suitable for transplantation is a pressing issue.&#xD;
&#xD;
      Experimental and clinical evidence demonstrate the harmful short and long-term effects of&#xD;
      ischemia-reperfusion injury (IRI) of the donor organ on the outcome of the intervention&#xD;
      performed. Severe manifestations of IRI of the liver transplant (LT) is one of the main&#xD;
      reasons for the increased length of hospitalization, the high cost of treating patients&#xD;
      during the post- surgery period, the development of persistent early allograft dysfunction or&#xD;
      loss, frequent crises of acute rejection, acute renal and multiple organ failure, and&#xD;
      mortality of the operated patients. IRI caused by the termination and subsequent restoration&#xD;
      of blood flow is more or less inevitable for all donor organs. The mechanism of&#xD;
      ischemia-reperfusion syndrome involves interaction between vascular endothelium, interstitial&#xD;
      space, circulating cells and a variety of biochemical reactions, with the primary link in the&#xD;
      chain of pathological processes of local and generalized nature being microcirculatory&#xD;
      disorders. Early allograft dysfunction is an important predictor of severe complications and&#xD;
      mortality after OLT.&#xD;
&#xD;
      The incidence of early allograft dysfunction is approximately 25% (ranging from 9.3 to 43.7%&#xD;
      subject to different definitions and classifications of the condition). Retrospective&#xD;
      evaluation of the incidence of early allograft dysfunction performed in the Russian leading&#xD;
      transplantation institution - N.V. Sklifosovsky Research Institute of Emergency Care,&#xD;
      confirmed the development of this type of complication in 25% of cases (N = 202). Death has&#xD;
      occurred in the population of patients with early allograft dysfunction at almost twice the&#xD;
      rate of patients with normal functioning of the transplant during the first 7 days after OLT&#xD;
      (p &lt; 0.005).&#xD;
&#xD;
      Therefore, as yet, the search of the drugs that may be effective in the prevention of early&#xD;
      allograft dysfunction is still a relevant issue.&#xD;
&#xD;
      Reparixin is a new, potent and specific inhibitor of chemokine CXCL8 (Interleukin-8). With&#xD;
      regard to the mechanism of action of Reparixin, its early preclinical development was aimed&#xD;
      at specific inhibition of migration of polymorphonuclear neutrophils and prevention of&#xD;
      ischemia- reperfusion injury.&#xD;
&#xD;
      Reparixin has received the orphan drug designation in EU in September 2001 and in USA in&#xD;
      January 2003 for prevention of delayed graft function after solid organ transplantation. More&#xD;
      recently orphan drug designation has been granted in EU (September 2011) for the &quot;prevention&#xD;
      of graft loss in pancreatic islet transplantation&quot; and in the US (September 2012) for the&#xD;
      &quot;prevention of graft loss in islet cell transplantation&quot;.&#xD;
&#xD;
      This pilot clinical study is designed to evaluate the efficacy and safety of Reparixin as an&#xD;
      agent to prevent early allograft dysfunction caused by ischemia-reperfusion injury in&#xD;
      patients undergoing orthotopic liver transplantation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2015</start_date>
  <completion_date type="Actual">March 31, 2017</completion_date>
  <primary_completion_date type="Actual">February 9, 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>% Early Allograft Dysfunction</measure>
    <time_frame>Week 1</time_frame>
    <description>% Early Allograft Dysfunction after Week 1 post transplant</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Primary nonfuntion</measure>
    <time_frame>Day 7</time_frame>
    <description>Primary nonfunction within 7 days after OLT defined by liver function tests</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall dysfunction</measure>
    <time_frame>Day 14</time_frame>
    <description>Overall indication of liver allograft disfunction, including:&#xD;
I) primary nonfuntion II) early allograft dysfunction defined as maximum alanine transferase (ALT) or aspartate transferase (AST) levels on days 1-7 of &gt;2000 U/ml, day 7 bilirubin level ≥10 mg/dl, or a day 7 international normalized ratio (INR) ≥1.7, III) extracorporeal detoxification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Liver Function normalization</measure>
    <time_frame>Month 12</time_frame>
    <description>Time for normalization of liver function parameters after OLT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality at month 12</measure>
    <time_frame>Month 12</time_frame>
    <description>Mortality within 1 year after OLT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Graft survival month 12</measure>
    <time_frame>Month 12</time_frame>
    <description>Graft survival at 1 year after OLT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AE</measure>
    <time_frame>Month 12</time_frame>
    <description>Adverse events during 1 years after OLT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of extracorporeal detoxification</measure>
    <time_frame>Month 12</time_frame>
    <description>The incidence of severe allograft dysfunction, which required extracorporeal detoxification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ALT</measure>
    <time_frame>Month 12</time_frame>
    <description>Change from baseline value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AST</measure>
    <time_frame>Month 12</time_frame>
    <description>Change from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GGT</measure>
    <time_frame>Month 12</time_frame>
    <description>Change from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Bilirubin</measure>
    <time_frame>Month 12</time_frame>
    <description>Change from baseline</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Ischemia-reperfusion Injury in Liver Transplant</condition>
  <condition>Early Allograft Dysfunction</condition>
  <arm_group>
    <arm_group_label>Reparixin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Reparixin 2.772 mg/kg/hour 168 hrs continuous intravenous infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care Procedures</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>No treatment; standard care procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Reparixin</intervention_name>
    <description>Reparixin 168 hrs continuous infusion</description>
    <arm_group_label>Reparixin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard care procedures</intervention_name>
    <description>Standard procedures for administration of Immunosuppressive and support post transplant therapies</description>
    <arm_group_label>Standard Care Procedures</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female patients aged 18 years and older needing a whole organ OLT, listed on&#xD;
             the waiting list for liver transplantation.&#xD;
&#xD;
          2. Severity score of the initial condition of the patient (hepatocellular dysfunction)&#xD;
             according to the scales of Child-Turcotte-Pugh ≥ 7 points or MELD 15-40 points (or&#xD;
             both).&#xD;
&#xD;
          3. The possibility of insertion of a central catheter for infusion of the study drug.&#xD;
&#xD;
          4. Signed Patient Informed Consent Form.&#xD;
&#xD;
          5. Ability to comply with all the requirements of the protocol.&#xD;
&#xD;
          6. Consent to use adequate contraception means throughout the study. The adequate&#xD;
             contraception methods include use of condom with spermicide.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients with any of the following conditions shall not be included in the study:&#xD;
&#xD;
          1. Split-liver transplantation or transplantation from a living donor.&#xD;
&#xD;
          2. Re-transplantation or multivisceral transplantation.&#xD;
&#xD;
          3. The presence of extrahepatic tumor foci or sepsis.&#xD;
&#xD;
          4. Gastrointestinal bleeding caused by portal hypertension within 3 months prior to&#xD;
             screening.&#xD;
&#xD;
          5. BMI less than 18.5 or more than 40 kg/m2.&#xD;
&#xD;
          6. HIV infection.&#xD;
&#xD;
          7. Significant cardiovascular disease at the present time or within 6 months prior to&#xD;
             screening, including: class III or IV chronic heart failure (the New York Heart&#xD;
             Association), myocardial infarction, unstable angina, hemodynamically significant&#xD;
             cardiac arrhythmias, ischemic or hemorrhagic stroke, uncontrolled arterial&#xD;
             hypertension.&#xD;
&#xD;
          8. Preoperative renal impairment (glomerular filtration rate estimated with the&#xD;
             Cockcroft-Gault formula ≤ 45 mL/min).&#xD;
&#xD;
          9. Significant, in the opinion of the Investigator, drug or alcohol abuse within 6 months&#xD;
             prior to screening.&#xD;
&#xD;
         10. Hypersensitivity to:&#xD;
&#xD;
               1. ibuprofen or to more than one non-steroidal anti-inflammatory drug (NSAID),&#xD;
&#xD;
               2. more than one medication belonging to the class of sulfonamides, such as&#xD;
                  sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib;&#xD;
                  hypersensitivity to sulphanilamide antibiotics alone (e.g. sulfamethoxazole) does&#xD;
                  not qualify for exclusion.&#xD;
&#xD;
         11. Pregnant or lactating women, or women planning a pregnancy during the clinical study,&#xD;
             fertile women not using adequate contraception methods.&#xD;
&#xD;
         12. Participation in another clinical study currently or within 30 days prior to&#xD;
             screening, use of any investigational drug within 30 days or 5 half-lives (whichever&#xD;
             is longer) prior to screening.&#xD;
&#xD;
         13. The patient's and his/her relatives' failure to understand the need for lifelong&#xD;
             immunosuppressive therapy, as well as the risk and difficulty of the pending operation&#xD;
             and the subsequent dynamic treatment.&#xD;
&#xD;
         14. Inability to read or write; unwillingness to understand and comply with the procedures&#xD;
             of the study protocol; failure to comply with the treatment, which, in opinion of the&#xD;
             Investigator, may affect the results of the study or the patient's safety and prevent&#xD;
             the patient from further participation in the study; any other associated medical or&#xD;
             serious mental conditions that make the patient unsuitable for participation in the&#xD;
             clinical study, limit the validity of informed consent or may affect the patient's&#xD;
             ability to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sergey Vladimirovich Zhuravel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>State Budgetary Health Institution of Moscow &quot;Scientific Research Institute of Emergency n.a. N.V. Sklifosovskiy of Moscow Healthcare Department&quot;</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Healthcare Organization &quot;9th City Clinical Hospital&quot;</name>
      <address>
        <city>Minsk</city>
        <zip>220045</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budgetary Health Institution &quot;Scientific Research Institute - Regional Clinical Hospital # 1 n.a. professor S.V. Ochapovskiy&quot; of the Ministry of Health of the Krasnodar Territory</name>
      <address>
        <city>Krasnodar</city>
        <state>Krasnodar Territory</state>
        <zip>350086</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budgetary Educational Institution of Higher Professional Education &quot;First Saint Petersburg State Medical University n.a. I.P. Pavlov&quot; of the Ministry of Health of the Russian Federation</name>
      <address>
        <city>St. Petersburg</city>
        <state>Saint Petersburg</state>
        <zip>197022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal State Budgetary Institution &quot;Academician V.I. Shumakov Federal Research Center of Transplantology and Artificial Organs&quot; Ministry of Health of the Russian Federation</name>
      <address>
        <city>Moscow</city>
        <zip>123182</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal State Budgetary Institution &quot;State Research Centre of the Russian Federation - Federal Medical Biophysical Centre n.a. A.I. Burnazyan&quot;</name>
      <address>
        <city>Moscow</city>
        <zip>123182</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budgetary Health Institution of Moscow &quot;Scientific Research Institute of Emergency n.a. N.V. Sklifosovskiy of Moscow Healthcare Department&quot;</name>
      <address>
        <city>Moscow</city>
        <zip>129090</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budgetary Health Institution of Novosibirsk Region &quot;State Novosibirsk Regional Clinical Hospital&quot;</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630087</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belarus</country>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>January 24, 2016</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>July 23, 2018</last_update_submitted>
  <last_update_submitted_qc>July 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Liver Transplant</keyword>
  <keyword>Ischemia-reperfusion injury</keyword>
  <keyword>Early allograft dysfunction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Reperfusion Injury</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03031470
org study id: TPL-RPX-01
nct id: NCT03031470
lead sponsor: 
has dmc: Yes
Liver transplantation is currently the treatment of choice for end-stage liver cirrhosis of
      different origin, as well as for a number of inborn metabolism disorders and liver tumors.
      The need to perform a liver transplantation is high and amounts to 10 - 20 patients per 1
      million population per year.

      Experimental and clinical evidence demonstrate the harmful short and long-term effects of
      ischemia-reperfusion injury (IRI) of the donor organ on the outcome of the intervention
      performed. Severe manifestations of IRI of the liver transplant (LT) is one of the main
      reasons for the increased length of hospitalization, the high cost of treating patients
      during the post- surgery period, the development of persistent early allograft dysfunction or
      loss, frequent crises of acute rejection, acute renal and multiple organ failure, and
      mortality of the operated patients.

      This pilot clinical study is designed to evaluate the efficacy and safety of Reparixin, which
      is a new, potent and specific inhibitor of chemokine CXCL8 (Interleukin-8), as an agent to
      prevent early allograft dysfunction caused by ischemia-reperfusion injury in patients
      undergoing orthotopic liver transplantation.
Liver transplantation is currently the treatment of choice for end-stage liver cirrhosis of
      different origin, as well as for a number of inborn metabolism disorders and liver tumors.
      The need to perform a liver transplantation is high and amounts to 10 - 20 patients per 1
      million population per year. The indication for liver transplantation is the presence of
      irreversible liver disease with estimated life expectancy of less than 12 months, absence of
      another treatment, presence of chronic liver disease, significantly reducing the patient's
      quality of life and ability to work, as well as progressive liver disease with a life
      expectancy less than in the case of liver transplantation (after liver transplantation 85% of
      patients survive for 1 year and 70% - for 5 years).

      Currently, about 200 liver transplantations are performed annually in Russia, which is more
      than 10 times lower than the existing need and is far below the number of similar operations
      performed abroad.

      The vast majority of liver transplants for adult recipients are performed using liver
      allografts from cadaveric donors. The rigorous list of requirements for a transplant
      restricts significantly the use of cadaveric liver. Thus, the need to expand the pool of
      donor organs suitable for transplantation is a pressing issue.

      Experimental and clinical evidence demonstrate the harmful short and long-term effects of
      ischemia-reperfusion injury (IRI) of the donor organ on the outcome of the intervention
      performed. Severe manifestations of IRI of the liver transplant (LT) is one of the main
      reasons for the increased length of hospitalization, the high cost of treating patients
      during the post- surgery period, the development of persistent early allograft dysfunction or
      loss, frequent crises of acute rejection, acute renal and multiple organ failure, and
      mortality of the operated patients. IRI caused by the termination and subsequent restoration
      of blood flow is more or less inevitable for all donor organs. The mechanism of
      ischemia-reperfusion syndrome involves interaction between vascular endothelium, interstitial
      space, circulating cells and a variety of biochemical reactions, with the primary link in the
      chain of pathological processes of local and generalized nature being microcirculatory
      disorders. Early allograft dysfunction is an important predictor of severe complications and
      mortality after OLT.

      The incidence of early allograft dysfunction is approximately 25% (ranging from 9.3 to 43.7%
      subject to different definitions and classifications of the condition). Retrospective
      evaluation of the incidence of early allograft dysfunction performed in the Russian leading
      transplantation institution - N.V. Sklifosovsky Research Institute of Emergency Care,
      confirmed the development of this type of complication in 25% of cases (N = 202). Death has
      occurred in the population of patients with early allograft dysfunction at almost twice the
      rate of patients with normal functioning of the transplant during the first 7 days after OLT
      (p < 0.005).

      Therefore, as yet, the search of the drugs that may be effective in the prevention of early
      allograft dysfunction is still a relevant issue.

      Reparixin is a new, potent and specific inhibitor of chemokine CXCL8 (Interleukin-8). With
      regard to the mechanism of action of Reparixin, its early preclinical development was aimed
      at specific inhibition of migration of polymorphonuclear neutrophils and prevention of
      ischemia- reperfusion injury.

      Reparixin has received the orphan drug designation in EU in September 2001 and in USA in
      January 2003 for prevention of delayed graft function after solid organ transplantation. More
      recently orphan drug designation has been granted in EU (September 2011) for the "prevention
      of graft loss in pancreatic islet transplantation" and in the US (September 2012) for the
      "prevention of graft loss in islet cell transplantation".

      This pilot clinical study is designed to evaluate the efficacy and safety of Reparixin as an
      agent to prevent early allograft dysfunction caused by ischemia-reperfusion injury in
      patients undergoing orthotopic liver transplantation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: % Early Allograft Dysfunction
time frame: Week 1
description: % Early Allograft Dysfunction after Week 1 post transplant
measure: Primary nonfuntion
time frame: Day 7
description: Primary nonfunction within 7 days after OLT defined by liver function tests
measure: Overall dysfunction
time frame: Day 14
description: Overall indication of liver allograft disfunction, including:
I) primary nonfuntion II) early allograft dysfunction defined as maximum alanine transferase (ALT) or aspartate transferase (AST) levels on days 1-7 of >2000 U/ml, day 7 bilirubin level ≥10 mg/dl, or a day 7 international normalized ratio (INR) ≥1.7, III) extracorporeal detoxification
measure: Time to Liver Function normalization
time frame: Month 12
description: Time for normalization of liver function parameters after OLT
measure: Mortality at month 12
time frame: Month 12
description: Mortality within 1 year after OLT
measure: Graft survival month 12
time frame: Month 12
description: Graft survival at 1 year after OLT
measure: AE
time frame: Month 12
description: Adverse events during 1 years after OLT
measure: Incidence of extracorporeal detoxification
time frame: Month 12
description: The incidence of severe allograft dysfunction, which required extracorporeal detoxification
measure: ALT
time frame: Month 12
description: Change from baseline value
measure: AST
time frame: Month 12
description: Change from baseline
measure: GGT
time frame: Month 12
description: Change from baseline
measure: Total Bilirubin
time frame: Month 12
description: Change from baseline
arm group label: Reparixin
arm group type: Experimental
description: Reparixin 2.772 mg/kg/hour 168 hrs continuous intravenous infusion
arm group label: Standard Care Procedures
arm group type: Other
description: No treatment; standard care procedure
intervention type: Drug
intervention name: Reparixin
description: Reparixin 168 hrs continuous infusion
arm group label: Reparixin
intervention type: Other
intervention name: Standard care procedures
description: Standard procedures for administration of Immunosuppressive and support post transplant therapies
arm group label: Standard Care Procedures
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sergey Vladimirovich Zhuravel, MD
role: Principal Investigator
affiliation: State Budgetary Health Institution of Moscow "Scientific Research Institute of Emergency n.a. N.V. Sklifosovskiy of Moscow Healthcare Department"
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belarus
country: Russian Federation
responsible party type: Sponsor
mesh term: Reperfusion Injury
mesh term: Ischemia