16 completed. 16 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 16 | Completed 16 |
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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 |
|---|---|---|---|---|---|---|
| An Open-label, Multicenter Study to Assess the Pharmacokinetics (PK), Safety, and Tolerability of Subcutaneous IgPro20 in Immunoglobulin (IG) Treatment-naïve Participants With Primary Immunodeficiency (PID) IgPro - Primary Immunodeficiency | Phase 4 | Completed | CSL Behring | 8 | 2025-07-15 | 2026-07-16 |
| Safety Study in Subjects ≥ 12 Years of Age With Hereditary Angioedema Switching to Garadacimab Garadacimab - Hereditary Angioedema | Phase 4 | Completed | CSL Behring | 18 | 2025-04-28 | 2026-07-23 |
| Safety and Tolerability of Higher Infusion Parameters of IgPro20 (Hizentra) in Subjects With Primary Immunodeficiency (PID) IgPro20 - Primary Immunodeficiency | Phase 4 | Completed | CSL Behring | 49 | 2017-02-01 | 2020-03-25 |
| PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding Prothrombin complex concentrate (Human), Fresh frozen plasma (FFP) - Bleeding, Blood Loss, Surgical | Phase 4 | Completed | Mayo Clinic | 106 | 2016-08-01 | 2022-06-07 |
| Study of Immune Deficiency Patients Treated With Subcutaneous Immunoglobulin (IgPro20, Hizentra®) on Weekly and Biweekly Schedules Subcutaneous Immune Globulin (Human) (Hizentra) - Primary Immune Deficiency, Secondary Immune Deficiency | Phase 4 | Completed | CSL Behring | 26 | 2016-03-15 | 2018-02-26 |
| Study of Voncento® in Subjects With Von Willebrand Disease Voncento - Von Willebrand Disease | Phase 4 | Completed | CSL Behring | 26 | 2015-10-05 | 2018-05-16 |
| Postmarketing Immunogenicity Study in HAE Subjects Treated With Berinert Berinert, lyophilizate for IV application containing 500 IU C1-INH to be reconstituted with 10 mL water for injection - Hereditary Angioedema Types I and II | Phase 4 | Completed | CSL Behring | 46 | 2011-11-01 | 2017-02-06 |
| A Safety Study of Intravenous Immunoglobulin in Patients With Chronic Immune Thrombocytopenic Purpura (ITP) IgPro10 - Immune Thrombocytopenic Purpura | Phase 4 | Completed | CSL Behring | 57 | 2011-11-01 | 2016-04-08 |
| Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for Cytomegalovirus Infection Valganciclovir, CMV hyperimmune globulin - Cytomegalovirus Disease | Phase 4 | Completed | Medical University of South Carolina | 40 | 2011-11-01 | 2018-10-04 |
| Open Label Use Of RiaStap During Aortic Reconstruction RiaSTAP - Coagulopathic Bleeding | Phase 4 | Completed | Duke University | 23 | 2010-12-01 | 2014-12-25 |
| Fibrinogen as an Alternative to FFP in Aortic Surgery. Fibrinogen concentrate, Fresh Frozen Plasma - Coagulopathy in Patients Having Thoraco-Abdominal Aneurysm Repair | Phase 4 | Completed | University of Edinburgh | 20 | 2010-06-01 | 2017-01-31 |
| Extension Study of Zemaira® i.v. Administration in Subjects With Emphysema Due to alpha1-proteinase Inhibitor Deficiency. Alpha1- proteinase inhibitor [human] - Emphysema, Alpha 1-proteinase Inhibitor Deficiency | Phase 4 | Completed | CSL Behring | 140 | 2008-04-01 | 2016-08-15 |
| Efficacy and Safety of Vivaglobin® in Previously Untreated Patients With Primary Immunodeficiency Vivaglobin - Common Variable Immunodeficiency, Agammaglobulinemia | Phase 4 | Completed | CSL Behring | 18 | 2007-03-01 | 2013-06-20 |
| Zemaira in Subjects With Emphysema Due to Alpha1-Proteinase Inhibitor Deficiency Alpha1-proteinase inhibitor, Placebo - Alpha1-proteinase Inhibitor Deficiency, Emphysema | Phase 4 | Completed | CSL Behring | 180 | 2006-03-01 | 2015-01-19 |
| Panel Reactive Antibody (PRA) Reduction in Sensitized Patients Awaiting Renal Transplantation CMVIG - End Stage Renal Disease | Phase 4 | Completed | Tampa General Hospital | 26 | 2002-01-01 | 2015-06-29 |
| Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex in Surgical Subjects With Von Willebrand Disease (vWD) Blood coagulation Factor VIII and vWF, human - Von Willebrand Disease, Blood Coagulation Disorders | Phase 4 | Completed | CSL Behring | 30 | 2001-10-01 | 2011-02-11 |
Primary Immunodeficiency Diseases (4) · Emphysema (2) · alpha 1-Antitrypsin Deficiency (2) · von Willebrand Diseases (2) · Agammaglobulinemia (1) · Angioedemas, Hereditary (1) · Blood Coagulation Disorders (1) · Blood Loss, Surgical (1) · Blood Platelet Disorders (1) · Bruton type agammaglobulinemia (1) · Common Variable Immunodeficiency (1) · Cytomegalovirus Infections (1) · Hematologic Diseases (1) · Hemophilia A (1) · Hemorrhage (1)
Fibrinogen (2) · Hizentra (2) · alpha 1-Antitrypsin (2) · cytomegalovirus-specific hyperimmune globulin (2) · Complement C1 Inhibitor Protein (1) · Factor IX (1) · Factor VIII (1) · Fluid Therapy (1) · Immunoglobulins, Intravenous (1) · Injections (1) · Respreeza (1) · Valganciclovir (1) · Vivaglobin (1) · Water (1) · gamma-Globulins (1)
United States (9) · Canada (6) · Germany (5) · Poland (4) · Romania (4) · Australia (2) · Bulgaria (2) · Czechia (2) · Denmark (2) · Estonia (2) · Finland (2) · Ireland (2) · Sweden (2) · United Kingdom (2) · Austria (1)
Alastair Nimmo, MBChB (1) · Elie Haddad, MD (1) · Gregory Nuttall, MD (1) · Ian Welsby, MD (1) · John Leone, MD, PhD (1) · Marylin J. Manco-Johnson, M.D. (1) · Michael Borte, MD (1) · Mikhail Rojavin (1) · Wieslaw Jedrzejczak (1)
PMID 26026936, PMID 30237305, PMID 21932110, PMID 27788880, PMID 27916480, PMID 33025378, PMID 33409867, PMID 35767271, PMID 36408876, PMID 39633218, PMID 39807668
2005 (1), 2015 (1), 2016 (1)