Pilot Study of Reparixin for Early Allograft Dysfunction Prevention in Liver Transplantation
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).
Timeline
- Start
- 2015-03-10
- Primary completion
- 2017-02-09
- Completion
- 2017-03-31
Outcome
Missed primary endpoint
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”
registry analysis (superiority test); Reparixin - PP vs Control - PP; p = 0.688; Fisher Exact NCT03031470 ↗
registry analysis (superiority test); Reparixin - mITT vs Control - mITT; p = 0.700; Fisher Exact NCT03031470 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Reparixin | Small molecule | 2.772 mg/kg | Intravenous |