4 completed, 1 terminated. 4 Phase 2, 3 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 4 | Completed 3, Terminated 1 |
| Phase 3 | 3 | Completed 2, Terminated 1 |
Follow Prolastin: new trials by email Literature Review of Prolastin trials Research Report on Prolastin
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 |
|---|---|---|---|---|---|---|
| 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 |
| Safety and Efficacy of (α1Proteinase Inhibitor, α1PI) in HIV Disease α1 Proteinase Inhibitor, Placebos - HIV Disease | Phase 2 / Phase 3 | Terminated | Institute for Human Genetics and Biochemistry | 12 | 2012-04-01 | 2020-08-31 |
| Therapy to Elevate CD4 Counts in HIV-1 Disease alpha-1-Proteinase Inhibitor - HIV Disease | Phase 2 / Phase 3 | Completed | Institute for Human Genetics and Biochemistry | 4 | 2006-12-01 | 2021-09-28 |
| 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 |
| Alpha-1-Antitrypsin (AAT) To Treat Emphysema In AAT-Deficient Patients (EXACTLE) Alpha1-Proteinase Inhibitor (Human), Albumin (Human) 20%, United States Pharmacopeia (USP) - Alpha 1-Antitrypsin Deficiency | Phase 2 | Completed | Grifols Therapeutics LLC | 77 | 2003-12-01 | 2014-08-21 |
Acquired Immunodeficiency Syndrome (2) · alpha 1-Antitrypsin Deficiency (2) · COVID-19 (1) · Congenital lobar emphysema (1) · Pulmonary Emphysema (1)
Grifols Therapeutics LLC (2) · Institute for Human Genetics and Biochemistry (2) · Instituto Grifols, S.A. (1)
United States (3) · United Kingdom (2) · Denmark (1) · Spain (1) · Sweden (1)
Asger Dirksen, MD PHD (1) · Cynthia Bristow, PhD (1) · Cynthia L Bristow, PhD (1) · Jose Cortes, MD (1) · Kim Hanna, MSc (1)
PMID 31824943, PMID 19196813, PMID 19251783, PMID 19483042, PMID 19678952, PMID 20920370, PMID 21617168, PMID 23226015, PMID 24229737