Efficacy and Safety of Reparixin in Pancreatic Islet Auto-transplantation

Summary

The study is a phase 2/3, multicenter, double-blind, parallel assignment study. It involves 100 adult recipients of an intra-hepatic pancreatic Islet Auto-Transplantation (IAT). The objective of this clinical trial is to assess whether reparixin leads to improved transplant outcome as measured by the proportion of insulin-independent patients following IAT. The safety of reparixin in the specific clinical setting will be also evaluated.

Timeline

Start

2014-02

Primary completion

2018-01

Completion

2018-01

Outcome

Missed primary endpoint

registry analysis (superiority test); Reparixin vs Placebo; p = 0.542; t-test -1.2 (95% CI -14.3 to 000); Cochran-Mantel-Haenszel NCT01967888 ↗

Drugs

Indications