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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of EAD (Early Allograft Dysfunction) Within 7 Days After OLT (PP Population)

Timeframe: within 7 day after the OLT

Incidence of EAD (Early Allograft Dysfunction) Within 7 Days After OLT (mITT Population)

Timeframe: within 7 day after the OLT

Trial details

NCT IDNCT03031470

SponsorDompé Farmaceutici S.p.A

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-02-09

Results submitted2024-01-31

View on ClinicalTrials.gov More Ischemia-reperfusion Injury in Liver Transplant trials