6 completed, 3 recruiting, 2 terminated, 1 active not recruiting. 13 Phase 3, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 13 | Completed 6, Recruiting 3, Terminated 2, Active not recruiting 1, Enrolling by invitation 1 |
| Phase 2 | 2 | Completed 2 |
Follow Subcutaneous Emphysema: new trials by email Literature Review of Subcutaneous Emphysema trials Research Report on Subcutaneous Emphysema
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 |
|---|---|---|---|---|---|---|
| A Non-inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Doses of Weekly SC Alpha1-PI 15% Compared With Corresponding Standard IV Alpha1-PI in Participants With Alpha1-Antitrypsin Deficiency (AATD) Alpha-1 15%, Liquid Alpha1-PI - Alpha 1 Antitrypsin Deficiency | Phase 3 | Recruiting | Grifols Therapeutics LLC | 40 | 2026-05-05 | 2026-10-26 |
| Study to Learn About the Safety of Fazirsiran and if it Can Help People With Alpha-1 Antitrypsin Liver Disease With Mild Liver Scarring (Fibrosis) Fazirsiran Injection, Placebo - Alpha1-Antitrypsin Deficiency | Phase 3 | Recruiting | Takeda | 50 | 2024-03-01 | 2026-11-12 |
| An Extension Study to Learn About the Long-Term Safety of Fazirsiran and if Fazirsiran Can Help People With Alpha-1 Antitrypsin Liver Disease Fazirsiran Injection - Alpha1-Antitrypsin Deficiency | Phase 3 | Active not recruiting | Takeda | 200 | 2023-08-08 | 2026-11-12 |
| Study to Check the Safety of Fazirsiran and Learn if Fazirsiran Can Help People With Liver Disease and Scarring (Fibrosis) Due to an Abnormal Version of Alpha-1 Antitrypsin Protein Fazirsiran Injection, Placebo - Alpha1-Antitrypsin Deficiency | Phase 3 | Recruiting | Takeda | 160 | 2023-03-06 | 2026-05-13 |
| 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 |
| Stage 1 Study of ARALAST NP and GLASSIA in A1PI Deficiency ARALAST NP 60 mg/kg, ARALAST NP 120 mg/kg, GLASSIA 60 mg/kg - Chronic Obstructive Pulmonary Disease, Alpha1-antitrypsin Deficiency | Phase 3 | Terminated | Baxalta now part of Shire | 7 | 2016-11-02 | 2021-05-13 |
| Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency Alpha-1 MP - Pulmonary Emphysema in Alpha-1 Antitrypsin Deficiency | Phase 3 | Enrolling by invitation | Grifols Therapeutics LLC | 290 | 2016-07-01 | 2026-06-23 |
| GLASSIA Safety, Immunogenicity, and Bronchoalveolar Lavage Study GLASSIA - Alpha1-antitrypsin Deficiency | Phase 3 | Completed | Baxalta now part of Shire | 34 | 2016-03-08 | 2021-10-14 |
| Efficacy and Safety of Alpha1-Proteinase Inhibitor (Human), Modified Process (Alpha-1 MP) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency (AATD) Alpha-1 MP, 0.9% Sodium Chloride for Injection, USP - Pulmonary Emphysema in Alpha-1 PI Deficiency | Phase 3 | Completed | Grifols Therapeutics LLC | 345 | 2014-04-01 | 2026-10-01 |
| International Study Evaluating the Safety and Efficacy of Inhaled, Human, Alpha-1 Antitrypsin (AAT) in Alpha-1 Antitrypsin Deficient Patients With Emphysema Kamada AAT for inhalation, Placebo - Emphysema | Phase 2 / Phase 3 | Completed | Kamada, Ltd. | 168 | 2009-12-01 | 2019-11-29 |
| Phase II/III Study of an Alpha-1 Proteinase Inhibitor (Kamada-API) in Individuals With Alpha-1 Antitrypsin Deficiency Kamada-API - Alpha 1-Antitrypsin Deficiency | Phase 2 / Phase 3 | Completed | Kamada, Ltd. | 50 | 2007-03-01 | 2007-10-17 |
| The Safety and Tolerability of Alpha-1 Modified Process (MP) In Subjects With Alpha-1-antitrypsin (AAT) Deficiency alpha-1 proteinase inhibitor (human) - Alpha 1-Antitrypsin Deficiency | Phase 3 | Completed | Grifols Therapeutics LLC | 38 | 2006-06-01 | 2014-08-19 |
| Comparison of Pharmacokinetic, Safety, Tolerability of Alpha-1 MP and Prolastin In Alpha1-antitrypsin Deficient Adults Alpha-1 MP, alpha-1 proteinase inhibitor (human) - Alpha 1-Antitrypsin Deficiency | Phase 3 | Completed | Grifols Therapeutics LLC | 24 | 2006-05-01 | 2014-09-09 |
alpha 1-Antitrypsin Deficiency (13) · Pulmonary Emphysema (6) · Emphysema (2) · Pulmonary Disease, Chronic Obstructive (2) · Genetic Diseases, Inborn (1) · Lung Diseases (1) · Lung Diseases, Obstructive (1) · Pathologic Processes (1) · Respiratory Tract Diseases (1)
Congenital, Hereditary, and Neonatal Diseases and Abnormalities (13) · Digestive System Diseases (13) · Liver Diseases (13) · Pathological Conditions, Signs and Symptoms (13) · Genetic Diseases, Inborn (12) · Lung Diseases (12) · Pathologic Processes (12) · Respiratory Tract Diseases (12) · Emphysema (11) · Chronic Disease (7) · Disease Attributes (7) · Lung Diseases, Obstructive (6) · Pulmonary Disease, Chronic Obstructive (5)
alpha 1-Antitrypsin (6) · Mp alpha1 receptor (3) · Inhalation (2) · Sodium Chloride (2) · 15-keto-17-phenyl-18,19,20-trinorprostaglandin F2 alpha-1-isopropyl ester (1) · Injections (1)
Grifols Therapeutics LLC (5) · Kamada, Ltd. (3) · Takeda (3) · Baxalta now part of Shire (2)
United States (11) · Canada (7) · Sweden (7) · Germany (6) · United Kingdom (6) · Denmark (5) · Poland (5) · Australia (4) · France (4) · Ireland (4) · Netherlands (4) · Portugal (4) · Spain (4) · Austria (3) · Belgium (3)
Kim Hanna, MSc (2) · Jan Stolk, Prof (1) · Jan Stolk, Professor (1) · Robert A Sandhaus, M.D. (1)
PMID 20920295, PMID 23822603, PMID 25727857, PMID 31467115, PMID 37665565
2023 (2), 2025 (1)