Clinical trials

Active, recruitment completed

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.

REP0112

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.

What is the purpose of this study?

The objective of this clinical trial is to assess whether Reparixin leads to improved transplant outcome in patients that undergo total pancreatectomy and islet auto transplantation (TP-IAT) for the treatment of chronic pancreatitis. The primary outcome is the analysis of the proportion of insulin-independent patients in Reparixin treated and placebo groups; measures of islet function are also implemented. The safety of reparixin in the specific clinical setting will be also evaluated.

Trial overview

Condition

Islet Auto-Transplantation after total pancreatectomy for chronic pancreatitis

Study Identifiers

NCT01967888

Study type

Interventional

Intervention

Drug: Reparixin
Drug: Placebo

Phase

II/III

Start date

Dec 2013

End Date

Oct2017

Enrollment Goal

100

Going deep into the trial

Eligibility/Recruitment

Age

≥18 years old

Gender

Accepts healthy volunteers

Key Criteria

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Inclusion

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Exclusion

Some information about patients involvement

Each patient will be involved in the study for 7 day hospital stay during pancreatectomy followed by islet transplantation, for all required measurements up to hospital discharge and for 2 post-transplant visits scheduled @ day 75+14 and 365+14 after the transplant.

Desired Outcomes

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Primary Outcomes

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Secondary Outcomes

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