Pilot Study of Reparixin for Early Allograft Dysfunction Prevention in Liver Transplantation

Exclusion Criteria

• •Patients with any of the following conditions shall not be included in the study:
• •1. Split-liver transplantation or transplantation from a living donor.
• •2. Re-transplantation or multivisceral transplantation.
• •3. The presence of extrahepatic tumor foci or sepsis.
• •4. Gastrointestinal bleeding caused by portal hypertension within 3 months prior to screening.
• •5. BMI less than 18.5 or more than 40 kg/m2.
• •6. HIV infection.
• •7. Significant cardiovascular disease at the present time or within 6 months prior to screening, including: class III or IV chronic heart failure (the New York Heart Association), myocardial infarction, unstable angina, hemodynamically significant cardiac arrhythmias, ischemic or hemorrhagic stroke, uncontrolled arterial hypertension.
• •8. Preoperative renal impairment (glomerular filtration rate estimated with the Cockcroft-Gault formula ≤ 45 mL/min).
• •9. Significant, in the opinion of the Investigator, drug or alcohol abuse within 6 months prior to screening.
• •10. Hypersensitivity to:
• •1. ibuprofen or to more than one non-steroidal anti-inflammatory drug (NSAID),
• •2. more than one medication belonging to the class of sulfonamides, such as sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib; hypersensitivity to sulphanilamide antibiotics alone (e.g. sulfamethoxazole) does not qualify for exclusion.
• •11. Pregnant or lactating women, or women planning a pregnancy during the clinical study, fertile women not using adequate contraception methods.
• •12. Participation in another clinical study currently or within 30 days prior to screening, use of any investigational drug within 30 days or 5 half-lives (whichever is longer) prior to screening.
• •13. The patient's and his/her relatives' failure to understand the need for lifelong immunosuppressive therapy, as well as the risk and difficulty of the pending operation and the subsequent dynamic treatment.
• •14. Inability to read or write; unwillingness to understand and comply with the procedures of the study protocol; failure to comply with the treatment, which, in opinion of the Investigator, may affect the results of the study or the patient's safety and prevent the patient from further participation in the study; any other associated medical or serious mental conditions that make the patient unsuitable for participation in the clinical study, limit the validity of informed consent or may affect the patient's ability to participate in the study.