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Clinical Trial Details

Trial ID: L1999
Source ID: NCT02520076
Associated Drug: Alpha-1 Antitrypsin
Title: Aralast NP in Islet Transplant
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 1 Diabetes Mellitus
Interventions: DRUG: Alpha-1 Antitrypsin
Outcome Measures: Primary: To demonstrate AAT efficacy in preventing non-immunologic loss of transplanted islet mass in a single-donor islet transplant., Insulin independence at day 90 post-transplant (initial, single-donor transplant), Day 90 post-transplant | Secondary: To demonstrate safety of AAT during islet isolation and culture, Post-isolation measurements, compared to current standard protocol isolation data, for the following parameters: * Endotoxin level * Microbiological culture \[bacterial (both aerobic and anaerobic), fungal, mycoplasma, and mycobacterium culture\], Day -1 pre-transplant|To demonstrate efficacy of AAT to improve islet isolation quantity and quality, Post-isolation measurements, compared to current standard protocol isolation data, for the following parameters: * Islet yield * Viability (SytoGreen/ethidium bromide) * Purity * Beta cell specific viability * Cell composition assay * Glucose stimulated insulin release * DNA content, Day -1 pre-transplant|To demonstrate safety of AAT in islet transplantation., Adverse Event/Serious Adverse Event morbidity within 1 year post-transplant, which includes the following: * Primary non-function (PNF) * End-organ dysfunction * Malignancy * Opportunistic infection * Inpatient hospitalization * Prolongation of existing hospitalization * A life-threatening event * Persistent or significant disability * Congenital anomaly or birth defect * Patient death, Year 1 post-transplant|To demonstrate AAT efficacy in the prevention of long-term metabolic burn-out., * Full graft function at 1 year after initial single-donor transplant, compared to retrospective controls (current standard of care induction). * Partial graft function at 1 year after initial single-donor transplant compared to retrospective controls (current standard of care induction)., Year 1 post-transplant
Sponsor/Collaborators: Sponsor: University of Alberta | Collaborators: Shire
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1|PHASE2
Enrollment: 5
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2015-08
Completion Date: 2019-09-30
Results First Posted:
Last Update Posted: 2022-05-24
Locations: University of Alberta, Edmonton, Alberta, T6G 2C8, Canada
URL: https://clinicaltrials.gov/show/NCT02520076