Study to Assess Efficacy & Safety of Reparixin in Pancreatic Islet Transplantation

PHASE3CompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

December 31, 2016

Study Completion Date

December 31, 2017

Conditions
Islet Transplantation in Diabetes Mellitus Type 1
Interventions
DRUG

Reparixin

Continuous i.v. infusion into a central vein for 7 days, starting approximately 12 hrs (6-18 hrs) before each pancreatic islet infusion.The Investigational Product (IP) were to be administered as an add-on treatment for the immunosuppressant regimen.

DRUG

Placebo

Continuous infusion at a volume/rate matching active treatment.The placebo was to be administered as well as an add-on treatment for the immunosuppressant regimen.

Trial Locations (9)

14021

Institute for Clinical and Experimental Medicine (IKEM), Diabetes Centre; Department of Diabetes., Prague

14186

Department of Transplantation Surgery; The Karolinska University Hospital, Stockholm

20132

Dipartimento di Medicina Interna e Specialistica; IRCCS Ospedale San Raffaele, Milan

20162

S.S.D. Diabetologia, Azienda Ospedaliera Ospedale Niguarda Ca' Granda, Piazza Ospedale Maggiore 3, Milan

20502

Department of Nephrology and Transplantation; Skane University Hospital, Malmo

41345

Transplant Institute - Sahlgrenska University Hospital, Gothenburg

60637

The University of Chicago Medical Center, Department of Surgery, Division of Abdominal Organ Transplantation, Chicago

75185

Division for Transplantation and Liver Surgery; Department of Surgery; Uppsala University Hospital, Uppsala

NE7 7DN

Institute of Transplantation, Newcastle upon Tyne Hospitals - NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne

All Listed Sponsors
lead

Dompé Farmaceutici S.p.A

INDUSTRY

NCT01817959 - Study to Assess Efficacy & Safety of Reparixin in Pancreatic Islet Transplantation | Biotech Hunter | Biotech Hunter