NCT02727608

Complement Inhibitor Eculizumab in Clinical Islet Transplantation

Induction With Complement Inhibitor Eculizumab in Clinical Islet Transplantation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Uppsala University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a dual centre, single arm, exploratory study of the possibility to use eculizumab (Soliris) to prevent/reduce destruction of islets of Langerhans after portal infusion of the islets in patients with diabetics accepted for islet transplant.

Detailed description

This is a dual centre, single arm, exploratory study of the possibility to use eculizumab (Soliris) to prevent/reduce destruction of islets of Langerhans after portal infusion of the islets in patients with diabetics accepted for islet transplant. Ten patients from 2 centres (Uppsala University Hospital and Karolinska University Hospital in Stockholm) will be transplanted. The purpose of the study is to investigate if selective complement inhibition by eculizumab combined with standard anticoagulation during and after transplantation can further reduce the extent of early tissue loss after portal infusion of islets.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Eculizumab	Intravenous infusion (1200 mg) over 35 minutes. Consecutive infusions (900 mg) on Days 1, 7 and 14.

Timeline

• Start date: 2016-05-15
• Primary completion: 2018-05-01
• Completion: 2018-06-01
• First posted: 2016-04-04
• Last updated: 2018-10-04

Locations

1 site across 1 country: Sweden