Ignite Creation Date:
2024-05-06 @ 12:52 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03867851
Status:
TERMINATED
Last Update Posted:
2024-05-16
First Post:
2019-03-05
Brief Title:
Study to Evaluate Safety and Efficacy of IBsolvMIR in Islet Transplantation
Sponsor:
TikoMed AB
Organization:
TikoMed AB
Study Overview
Official Title:
Open Randomized Active Comparator-controlled Multi-Center Study to Evaluate Safety and Efficacy of IBsolvMIR in Islet Transplantation
Status:
TERMINATED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow patient recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 21 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None