Table 3 A list of last decade clinical trials testing AAT safety and efficacy in conditions different from severe deficiency AAT according to clinicaltrials.gov, last access 15 july 2018
Study Title | Condition | Phase | Start Date | Status |
|---|---|---|---|---|
A proof-of-concept pilot trial of AAT for pre-emption of steroid refractory acute GVDH | GVDH | 2 | 2018 | Recruiting |
Multicenter trial of the effect of AAT on Islet Transplant engraftment and durability after Renal Transplant | Diabetes Mellitus, Type 1 | 2 | 2017 | Recruiting |
Anti-inflammatory therapy to improve outcomes in patients with Chronic Pancreatitis undergoing Total Pancreatectomy Islet Autotransplantation | Chronic Pancreatitis; Diabetes Mellitus, Type 1 | 4 | 2016 | Recruiting |
AAT enhances islet autograft survival | Chronic Pancreatitis | 1–2 | 2016 | Recruiting |
A phase 2/3 clinical study to evaluate the safety and efficacy of AAT as an add-on biopharmacotherapy to conventional steroid treatment in subjects with acute GVDH with lower gastrointestinal involvement | GVDH | 2–3 | 2016 | Terminated |
A proof-of-concept study evaluating the safety and efficacy of human AAT treatment in first Lung Transplantation | Transplantation, Lung Rejection | 2 | 2015 | Active, not recruiting |
Improving single donor success rate in clinical islet using AAT | Diabetes Mellitus, Type 1 | 1–2 | 2015 | Active, not recruiting |
A multicenter, randomized, placebo-controlled study to evaluate the safety and efficacy of a human plasma-derived AAT in subjects with new-onset Type 1 Diabetes Mellitus | Diabetes Mellitus, Type 1 | 2 | 2014 | Terminated |
Single dose administration of AAT for the amelioration of organ injury and post-operative bleeding in patients undergoing cardiac surgery with cariopulmonary bypass | Post Cardiac Surgery Systemic Inflammatory Response | 1–2 | 2014 | Unknown |
Pilot study of AAT: a novel treatment to mitigate Neuromyelitis Optica attacks | Neuromyelitis Optica | 1 | 2014 | Unknown |
Long-term treatment safety, tolerability and efficacy of AAT in Type 1 Diabetes | Diabetes Mellitus, Type 1 | 2 | 2013 | Completed |
AAT to quench the acute inflammatory response in ST-segment elevation Acute Myocardial Infarction | Acute Myocardial Infarction | 1–2 | 2013 | Completed |
Phase 2 study to evaluate the efficacy and safety of human AAT in the treatment of new onset Type 1 Diabetes | Diabetes Mellitus, Type 1 | 2 | 2013 | Completed |
Effects of Prolastin aerosol therapy on bacterial density in the airways of patients with CF | Cystic Fibrosis | 2 | 2013 | Terminated |
AAT in treating patients with acute GVDH | GVDH | 1–2 | 2012 | Completed |
Safety and tolerability of inhaled AAT once-a-day in patients with Cystic Fibrosis | Cystic Fibrosis | 2 | 2012 | Completed |
Safety and efficacy of AAT in HIV Disease | HIV Disease | 2–3 | 2012 | Terminated |
A pilot study of AAT in steroid refractory acute GVDH | GVDH | 2 | 2012 | Active, not recruiting |
The effects of AAT on the progression of Type-1 Diabetes in subjects with detectable C-peptide | Diabetes Mellitus, Type 1 | 1 | 2011 | Completed |
Proof-of-concept study of the safety, tolerability and efficacy of intravenous AAT in Type 1 Diabetes | Diabetes Mellitus, Type 1 | 1–2 | 2011 | Completed |
Safety and efficacy of inhaled AAT in preventing Bronchiolitis Obliterable Syndrome in Lung Transplant recipients | Transplantation, Lung Rejection | 2 | 2011 | Unknown |
Safety and tolerability study of AAT inhalation solution in patients with Cystic Fibrosis | Cystic Fibrosis | 1 | 2011 | Completed |
Effects of intravenous AAT on preserving beta-cell function in new-onset Type 1 Diabetes Mellitus | Diabetes Mellitus, Type 1 | 2 | 2010 | Withdrawn |