CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 104 enrolled
Drug / intervention
Reparixin +1 moredrug
Likely dose
Reparixin 2.772 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01967888
NCT01967888Phase 3Completed
CompareCT.gov

A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Assignment Study to Assess the Efficacy and Safety of Reparixin in Pancreatic Islet Auto-transplantation

Dompé Farmaceutici S.p.A·interventional·Posted Oct 23, 2013·Updated Nov 2, 2023

In Brief

A Phase 3 clinical trial evaluating Reparixin and Placebo for Pancreatectomy for Chronic Pancreatitis. Completed, enrolled 104 participants across 9 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPancreatectomy for Chronic Pancreatitis
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 23, 2013
Enrollment StartFeb 1, 2014
Primary CompletionJan 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 12.7 years ago

Interventions

Reparixindrug

Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour

Placebodrug

Physiologic solution administered at 0.25 mL/kg/hour