| Trial ID: | L7248 |
| Source ID: | NCT03867851
|
| Associated Drug: |
Ibsolvmir
|
| Title: |
Study to Evaluate Safety and Efficacy of IBsolvMIR in Islet Transplantation
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: IBsolvMIR|DRUG: Heparin
|
| Outcome Measures: |
Primary: Bleeding events, Bleeding events after islet transplantation with total dose of 27 mg/kg BW IBsolvMIR in comparison to active comparator Heparin, Up to 44 days.|Other AEs/SAEs after islet transplantation, Other AEs/SAEs after islet transplantation with total dose of 27 mg/kg BW IBsolvMIR in comparison to active comparator Heparin, Up to 44 days. | Secondary: Difference between groups in levels of biomarkers, Difference between groups in levels of biomarkers after transplantation, Within 7 days.|Change in C-peptide / (glucose x creatinine) ratio (CPGCR), Change in CPGCR at day 14 compared to baseline. CPGCR is calculated by: C-peptide (ng/mL) / ( glucose (mg/dL) x creatinine ratio (mg/dL) ), Within 14 days.
|
| Sponsor/Collaborators: |
Sponsor: TikoMed AB
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
7
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2021-02-08
|
| Completion Date: |
2024-05-13
|
| Results First Posted: |
|
| Last Update Posted: |
2024-05-16
|
| Locations: |
Leiden University Medical Center, Leiden, Zuid-Holland, 2300 RC, Netherlands|Oslo Universitetssykehus HF, Oslo, Norway|Sahlgrenska sjukhuset, Göteborg, Sweden|Karolinska Universitetssjukhuset Huddinge, Stockholm, Sweden|Akademiska sjukhuset, Uppsala, Sweden
|
| URL: |
https://clinicaltrials.gov/show/NCT03867851
|
