31 completed, 9 terminated, 6 withdrawn, 4 recruiting. 31 Phase 2, 12 Phase 3, 9 Phase 1, 9 Phase 4, 1 Not applicable.
Follow alpha 1-Antitrypsin: new trials by email Literature Review of alpha 1-Antitrypsin trials Research Report on alpha 1-Antitrypsin
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Phase 4, Double-blind Study Evaluating the Response on Computed Tomography (CT) Lung Density Decline Rates of Respreeza / Zemaira Weekly for 3 Years in Adults With alpha1 Antitrypsin Deficiency (AATD) CE1226 - Alpha1 Antitrypsin Deficiency, Alpha1-Proteinase Inhibitor Deficiency | Phase 4 | Recruiting | CSL Behring | 270 | 2026-09-29 | 2026-10-16 |
| UltraSound Guided Distal Radial Artery vS Conventional Transradial Access for Interventional Coronary Angiography coronary angiography - Radial Artery Access, Distal Radial Artery Access (dTRA) | Not applicable | Recruiting | University Hospital of Patras | 1400 | 2026-05-12 | 2026-06-01 |
| Intravenous Alpha-1 Antitrypsin for Hospitalized Patients With COPD Exacerbations (AECOPD Study) alpha1-proteinase inhibitor, produced from the plasma of human donors (Prolastin 1000 mg, powder and solvent for solution for infusion), Placebo - Acute Exacerbation Chronic Obstructive Pulmonary Disease | Phase 2 | Not yet recruiting | Fondazione IRCCS Policlinico San Matteo di Pavia | 36 | 2025-10-01 | 2025-08-24 |
| Effect of Alpha-1 Antitrypsin Supplementation on Alcohol-Associated Hepatitis Alfa1 Antitrypsin - Alcohol-Associated Hepatitis | Phase 2 | Recruiting | Medical University Innsbruck | 16 | 2025-06-18 | 2026-10-09 |
| Zemaira Eosinophilic Esophagitis Pilot Study Alpha-proteinase inhibitor - Eosinophilic Esophagitis | Phase 2 | Recruiting | Children's Hospital Medical Center, Cincinnati | 15 | 2025-05-15 | 2025-12-17 |
| A Study of RYMPHYSIA for Alpha1-Proteinase Inhibitor (A1PI) Therapy in Adults With A1PI Deficiency and Chronic Obstructive Pulmonary Disease (COPD)-Emphysema RYMPHYSIA, Another Available A1PI - Chronic Obstructive Pulmonary Disease (COPD), Alpha1-Antitrypsin Deficiency | Phase 4 | Withdrawn | Takeda | 2024-01-01 | 2023-05-06 | |
| Study of SAR447537 (INBRX-101) Compared to Plasma-derived A1PI Therapy in Adults With AATD Emphysema SAR447537, Zemaira - Alpha 1-Antitrypsin Deficiency, Emphysema | Phase 2 | Completed | Sanofi | 99 | 2023-10-12 | 2025-08-11 |
| Bronchiectasis Alpha-1 Augmentation Trial- Modulating Airway Neutrophil Function Alpha 1-Proteinase Inhibitor 180mg/kg, Alpha 1-Proteinase Inhibitor 120mg/kg, Sodium chloride - Bronchiectasis Adult | Phase 4 | Completed | University of Dundee | 20 | 2022-11-01 | 2024-09-03 |
| ARALAST NP Alpha-1 Lung Density Chronic Obstructive Pulmonary Disease-Emphysema (COPD-E) Study ARALAST NP - Chronic Obstructive Pulmonary Disease, Alpha1-antitrypsin Deficiency | Phase 4 | Withdrawn | Shire | 2021-03-08 | 2020-09-14 | |
| Study to Evaluate the Safety and Efficacy of Liquid Alpha1-Proteinase Inhibitor (Human) in Hospitalized Participants With Coronavirus Disease (COVID-19) Liquid Alpha1-Proteinase Inhibitor (Human), Placebo, Standard Medical Treatment - COVID-19 | Phase 2 | Terminated | Grifols Therapeutics LLC | 57 | 2021-01-29 | 2023-03-22 |
| Aralast NP With Antiviral Treatment and Standard of Care Versus Antiviral Treatment With Standard of Care in Hospitalized Patients With Pneumonia and COVID-19 Infection alpha1-proteinase inhibitor, Antiviral Agents - Covid19, Pneumonia, Viral | Phase 3 | Withdrawn | Blessing Corporate Services, Inc | 2021-01-01 | 2020-12-21 | |
| Study to Evaluate the Safety and Efficacy of Prolastin in Hospitalized Subjects With COVID-19 Prolastin, Standard Medical Treatment - COVID-19 | Phase 2 | Completed | Instituto Grifols, S.A. | 100 | 2020-07-29 | 2021-07-08 |
| Treatment of GVHD in Hematopoietic Stem Cell Transplant (HSCT) Recipients Using AAT Plus Corticosteroids (CS) Compared With Corticosteroids Alone Alpha-1 antitrypsin (AAT), Placebo - Graft Versus Host Disease (GVHD) | Phase 3 | Completed | CSL Behring | 136 | 2020-01-09 | 2026-07-28 |
| Phase III, Efficacy and Safety of "Kamada-AAT for Inhalation" Alpha 1-Antitrypsin, Placebo - Alpha 1-Antitrypsin Deficiency | Phase 3 | Terminated | Kamada, Ltd. | 98 | 2019-11-25 | 2026-08-12 |
| The Safety and Efficacy of Alpha-1 Antitrypsin (AAT) for the Prevention of Graft-versus-host Disease (GVHD) in Patients Receiving Hematopoietic Cell Transplant AAT, Placebo - Acute-graft-versus-host Disease | Phase 2 / Phase 3 | Terminated | CSL Behring | 222 | 2019-03-27 | 2026-09-09 |
| A Proof of Concept Pilot Trial of Alpha-1-Antitrypsin for Pre-Emption Of Steroid-Refractory Acute GVHD Alpha 1-Antitrypsin - Graft-versus-host-disease, GVHD | Phase 2 | Completed | John Levine | 30 | 2018-08-17 | 2021-07-12 |
| Study Comparing Weekly Intravenous Administration of OctaAlpha1 With a Marketed Preparation Glassia® in Subjects With Alpha-1-antitrypsin Deficiency OctaAlpha1, Glassia - Alpha 1-Antitrypsin Deficiency | Phase 2 | Withdrawn | Octapharma | 2018-07-01 | 2018-04-10 | |
| A Phase 2/3 Study of GLASSIA for the Treatment of Acute GvHD GLASSIA, methylprednisolone or equivalent steroid, Albumin - Graft Versus Host Disease | Phase 2 / Phase 3 | Terminated | Baxalta now part of Shire | 1 | 2017-04-26 | 2021-01-13 |
| Multicenter Trial of the Effect of AAT on Islet Transplant Engraftment and Durability After Renal Transplant Alpha 1-Antitrypsin, Islet Transplantation, Thymoglobulin - Kidney Transplant, Type 1 Diabetes | Phase 2 | Completed | Massachusetts General Hospital | 2 | 2017-01-01 | 2023-12-22 |
| Anti-inflammatory Therapy to Improve Outcomes After TPIAT etanercept, Alpha 1-Antitrypsin - Pancreatitis, Chronic; Diabetes; Transplant | Phase 4 | Completed | University of Minnesota | 43 | 2016-12-01 | 2026-06-09 |
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alpha 1-Antitrypsin Deficiency (26) · Diabetes Mellitus, Type 1 (7) · Emphysema (6) · Graft vs Host Disease (6) · Diabetes Mellitus (5) · Pulmonary Disease, Chronic Obstructive (4) · COVID-19 (3) · Cystic Fibrosis (3) · Acquired Immunodeficiency Syndrome (2) · Inflammation (2) · Pulmonary Emphysema (2) · Bronchiolitis Obliterans Syndrome (1) · Congenital chloride diarrhea (1) · Congenital lobar emphysema (1) · Disease (1)
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