Study to Evaluate Safety and Efficacy of IBsolvMIR in Islet Transplantation
Status:
Recruiting
Trial end date:
2022-02-28
Target enrollment:
Participant gender:
Summary
This is a Phase II open, randomized, active comparator-controlled multi center study in
patients with severe type-1 diabetes. This is a two-armed study where patients are randomized
in a 2:1 ratio between IBsolvMIR and heparin. Eighteen patients are planned to be included.
The study consists of up to 8 visits; screening, transplantation surgery with bolus
administration of study drug or active comparator, IBsolvMIR doses on day 1, 3 and 6 after
surgery, follow up visits on day 7 and 14, and follow-up phone call on day 44.
The primary endpoint is to study AEs up to 44 days following study drug administration. The
secondary endpoints are to evaluate changes in TAT, C-peptide, C3a and HGF at baseline and
during the first 24 hours after study drug administration, as well as evaluate a change in
levels of C-peptide-glucose-creatinine ratio on day 14 compared to baseline.