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

NCT03031470 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-01-07

Study results available
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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).

Conditions

  • Ischemia-reperfusion Injury in Liver Transplant
  • Early Allograft Dysfunction

Interventions

DRUG

Reparixin

Reparixin was administered as a continuous intravenous infusion for 7 days (Day 0 to Day 6) (168 hours). Reparixin was provided as 33 mg/ml concentrated solution to be diluted for i.v. infusion, packaged into 250 mL clear glass vials. To give a final concentration of 11 mg/mL, the content of a vial (250 ml) was diluted with 500 ml of 0.9% sterile saline to a total volume of 750 ml. The dosing solution was placed in a 1000 ml sterile empty Infusion Bag. Dosing solutions were to be used within 72 h from preparation, unless more restrictive rules. Reparixin infusion started approximately 60-90 minutes before the anticipated time of OLT. Infusion interruption was allowed for no more than 60 min. All patients received standard immunosuppressive therapy in accordance with the Russian Transplant Society Guidelines for liver transplantation. Patients and allograft survival were monitored up to 1 year after OLT.

OTHER

Control

The patients who were randomized in the control group, did not receive any study therapy. The patients of both groups received the standard immunosuppressive therapy with Tacrolimus only or together with mycophenolates, or a combination of Tacrolimus/Cyclosporine with mycophenolates and/or glucocorticosteroids. The patients with hepatocellular carcinoma and impaired renal function could receive a combination of drugs that includes everolimus. Basiliximab in association with methylprednisolone was used for the induction of immunosuppression.

Sponsors & Collaborators

  • Dompé Farmaceutici S.p.A

    lead INDUSTRY

Principal Investigators

  • Sergey Vladimirovich Zhuravel, MD · Moscow Scientific Research Institute of Emergency, NV Sklifosovskiy of Moscow Healthcare Department

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-10
Primary Completion
2017-02-09
Completion
2017-03-31

Countries

  • Belarus
  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03031470 on ClinicalTrials.gov