Pilot Study of Reparixin for Early Allograft Dysfunction Prevention in Liver Transplantation (NCT03031470) | Clinical Trial Compass
TerminatedPhase 2
Pilot Study of Reparixin for Early Allograft Dysfunction Prevention in Liver Transplantation
Stopped: Taking into account that 5 out of 22 patients in the Reparixin group experienced EAD during the first stage of the study, according to the Protocol and the DMC conclusion, it was decided on the early termination of the study
Belarus, Russia40 participantsStarted 2015-03-10
Plain-language summary
The objective of the study is to evaluate the efficacy and safety of Reparixin treatment (2.772 mg/kg body weight/hour intravenous continuous infusion for 7 days) based on incidence of early allograft dysfunction within the first 7 days after orthotopic liver transplantation (OLT) and overall indicators of allograft dysfunction in the early postoperative period (within 14 days after the OLT).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male and female patients aged 18 years and older needing a whole organ OLT, listed on the waiting list for liver transplantation.
✓. Severity score of the initial condition of the patient (hepatocellular dysfunction) according to the scales of Child-Turcotte-Pugh ≥ 7 points or MELD 15-40 points (or both).
✓. The possibility of insertion of a central catheter for infusion of the study drug.
✓. Signed Patient Informed Consent Form.
✓. Ability to comply with all the requirements of the protocol.
✓. Consent to use adequate contraception means throughout the study. The adequate contraception methods include use of condom with spermicide.
Exclusion criteria
✕. Split-liver transplantation or transplantation from a living donor.
✕. Re-transplantation or multivisceral transplantation.
✕. The presence of extrahepatic tumor foci or sepsis.
What they're measuring
1
Incidence of EAD (Early Allograft Dysfunction) Within 7 Days After OLT (PP Population)
Timeframe: within 7 day after the OLT
2
Incidence of EAD (Early Allograft Dysfunction) Within 7 Days After OLT (mITT Population)
✕. Gastrointestinal bleeding caused by portal hypertension within 3 months prior to screening.
✕. BMI less than 18.5 or more than 40 kg/m2.
✕. HIV infection.
✕. 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.
✕. Preoperative renal impairment (glomerular filtration rate estimated with the Cockcroft-Gault formula ≤ 45 mL/min).