NCT03867851

Study to Evaluate Safety and Efficacy of IBsolvMIR in Islet Transplantation

Open, Randomized, Active Comparator-controlled, Multi-Center Study to Evaluate Safety and Efficacy of IBsolvMIR® in Islet Transplantation

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: TikoMed AB · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	IBsolvMIR	Study drug IBsolvMIR
DRUG	Heparin	Clinical praxis

Timeline

• Start date: 2021-02-08
• Primary completion: 2024-05-13
• Completion: 2024-05-13
• First posted: 2019-03-08
• Last updated: 2024-05-16

Locations

5 sites across 3 countries: Netherlands, Norway, Sweden