Clinical trials

Active, recruitment completed

A phase 3, multicenter, randomized, double-blind, parallel assignment study to assess the efficacy and safety of reparixin in pancreatic islet transplantation

REP0211

A phase 3, multicenter, randomized, double-blind, parallel assignment study to assess the efficacy and safety of reparixin in pancreatic islet transplantation

What is the purpose of this study?

The chemokine CXCL8 plays a key role in the recruitment and activation of polymorphonuclear neutrophils in post-ischemia reperfusion injury after organ transplantion. Reparixin is the first low molecular weight blocker of CXCL8 biological activity in clinical development. Thus, the use of Reparixin may emerge as a potential key component in the sequentially integrated approach to immunomodulation and control of non specific inflammatory events surrounding the early phases of pancreatic islet transplantation in type 1 diabetes (T1D) patients.

Trial overview

Condition

Islet Transplantation in Diabetes Mellitus Type 1

Study Identifiers

NCT01817959

Study type

Interventional

Intervention

Drug: Reparixin
Drug: Placebo

Phase

III

Start date

Oct 2012

End Date

Oct2016

Enrollment Goal

42

Going deep into the trial

Eligibility/Recruitment

Age

 
18
 
70

Gender

Accepts healthy volunteers

Key Criteria

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Inclusion

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Exclusion

Some information about patients involvement

Study participation will last for a period of 12 to 24 months as a maximum, depending on whether patient receives 1 or 2 pancreatic and on the time elapsed between the two transplants.

Desired Outcomes

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Primary Outcomes

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Secondary Outcomes

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