11 completed, 3 terminated, 1 enrolling by invitation, 1 unknown. 8 Phase 2, 6 Phase 3, 2 Phase 1, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 8 | Completed 4, Terminated 2, Enrolling by invitation 1, Withdrawn 1 |
| Phase 3 | 6 | Completed 5, Enrolling by invitation 1 |
| Phase 1 | 2 | Completed 2 |
| Phase 4 | 1 | Completed 1 |
Follow Hereditary Angioedema Types I and II: new trials by email Literature Review of Hereditary Angioedema Types I and II trials Research Report on Hereditary Angioedema Types I and II
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 of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema Deucrictibant, Placebo - Hereditary Angioedema, Hereditary Angioedema Type I | Phase 3 | Completed | Pharvaris Netherlands B.V. | 134 | 2024-02-26 | 2025-11-21 |
| Extension Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema deucrictibant - Hereditary Angioedema, Hereditary Angioedema Type I | Phase 2 / Phase 3 | Enrolling by invitation | Pharvaris Netherlands B.V. | 150 | 2022-12-28 | 2026-07-21 |
| Dose-ranging Study of Oral PHA-022121 for Prophylaxis Against Angioedema Attacks in Patients With Hereditary Angioedema Type I or Type II Deucrictibant low dose, Deucrictibant high dose, Placebo - Hereditary Angioedema, Hereditary Angioedema Type I | Phase 2 | Terminated | Pharvaris Netherlands B.V. | 34 | 2022-04-19 | 2026-08-17 |
| A Trial to Evaluate the Efficacy and Safety of Different Doses of KVD824 for Prophylactic Treatment of HAE Type I or II KVD824, Placebo to KVD824 - Angioedema, Hereditary, Types I and II | Phase 2 | Terminated | KalVista Pharmaceuticals, Ltd. | 33 | 2021-11-18 | 2026-05-06 |
| Dose-ranging Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema Deucrictibant, Placebo - Hereditary Angioedema, Hereditary Angioedema Type I | Phase 2 | Completed | Pharvaris Netherlands B.V. | 74 | 2021-02-03 | 2025-12-17 |
| Hereditary Angioedema Kininogen Assay Hereditary Angioedema | Terminated | CENTOGENE GmbH Rostock | 59 | 2019-09-01 | 2022-03-10 | |
| Biomarker for Hereditary AngioEdema Disease C1 Esterase Inhibitor Deficiency, Angio Edema | Completed | CENTOGENE GmbH Rostock | 42 | 2018-08-20 | 2022-03-24 | |
| Global Registry to Gather Data on Natural History of Patients With Hereditary Angioedema Type I and II functional and antigenic C1 inhibitor - Hereditary Angioedema Type I and II | Unknown | HAE Global Registry Foundation | 220 | 2017-10-01 | 2019-02-05 | |
| A Study to Evaluate the Long-term Clinical Safety and Efficacy of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema C1-esterase inhibitor - Hereditary Angioedema Types I and II | Phase 3 | Completed | CSL Behring | 126 | 2014-12-31 | 2018-11-14 |
| A Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema Low-volume C1-esterase inhibitor, Higher-volume C1-esterase inhibitor, Low-volume placebo - Hereditary Angioedema Types I and II | Phase 3 | Completed | CSL Behring | 90 | 2014-01-01 | 2021-01-29 |
| Study to Assess the Tolerability and Safety of Ecallantide in Children and Adolescents With Hereditary Angioedema Ecallantide subcutaneous dosing - Hereditary Angioedema Types I and II | Phase 2 | Withdrawn | NYU Langone Health | 2013-08-01 | 2023-03-31 | |
| A Study to Evaluate the Safety and Pharmacokinetics of Two Formulations of C1-esterase Inhibitor Berinert, CSL830 - Hereditary Angioedema Types I and II | Phase 1 | Completed | CSL Behring | 16 | 2013-01-01 | 2013-04-05 |
| A Study to Evaluate the Clinical Pharmacology and Safety of C1-esterase Inhibitor Administered by the Subcutaneous Route C1-esterase inhibitor - single intravenous dose, C1-esterase inhibitor - subcutaneous low dose, C1-esterase inhibitor - subcutaneous medium dose - Hereditary Angioedema Types I and II | Phase 1 / Phase 2 | Completed | CSL Behring | 18 | 2012-04-01 | 2021-02-01 |
| 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 |
| C1-Esteraseremmer-N for the Treatment of Hereditary (and Acquired) Angioedema C1 inhibitor concentrate (C1-esteraseremmer-N) - Angioedema | Phase 2 / Phase 3 | Completed | Prothya Biosolutions | 6 | 2006-11-01 | 2009-05-04 |
| C1-Esteraseremmer-N for the Treatment of Hereditary (and Acquired) Angioedema C1 inhibitor concentrate (C1-esteraseremmer-N) - Angioedema | Phase 3 | Completed | Prothya Biosolutions | 15 | 2006-02-01 | 2009-05-04 |
| Kinetics, Efficacy and Safety of C1-Esteraseremmer-N C1 inhibitor concentrate - Hereditary Angioedema Type I, Angioneurotic Edema | Phase 2 | Completed | Prothya Biosolutions | 12 | 2005-09-01 | 2009-05-04 |
Angioedemas, Hereditary (9) · Angioedema (5) · Hereditary Angioedema Type III (3) · Acquired angioedema (2)
Cardiovascular Diseases (17) · Hypersensitivity (17) · Hypersensitivity, Immediate (17) · Immune System Diseases (17) · Skin Diseases (17) · Skin Diseases, Vascular (17) · Skin and Connective Tissue Diseases (17) · Urticaria (17) · Vascular Diseases (17) · Angioedema (12) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (9) · Genetic Diseases, Inborn (9) · Hereditary Complement Deficiency Diseases (9) · Immunologic Deficiency Syndromes (9) · Primary Immunodeficiency Diseases (9)
Complement C1 Inhibitor Protein (3) · Genetic Testing (1) · Injections (1) · Water (1)
CSL Behring (5) · Pharvaris Netherlands B.V. (4) · Prothya Biosolutions (3) · CENTOGENE GmbH Rostock (2) · HAE Global Registry Foundation (1) · KalVista Pharmaceuticals, Ltd. (1) · NYU Langone Health (1)
Germany (9) · United States (9) · Italy (8) · Canada (7) · Hungary (7) · United Kingdom (7) · Bulgaria (6) · Czechia (6) · Netherlands (6) · Poland (6) · Australia (5) · Romania (5) · Spain (5) · France (4) · Israel (4)
M. M. Levi, Prof. Dr. (3) · Peter Bauer, MD (2) · Marc Riedl, MD (1) · Marcus Maurer, Prof MD (1) · Mark A Davis-Lorton, MD (1) · Mikhail Rojavin (1)
PMID 36326435, PMID 26016741, PMID 27788880, PMID 28328347, PMID 30772477, PMID 31485239, PMID 32042283, PMID 33588897, PMID 41865746, PMID 41865747, PMID 42849489
2014 (1), 2023 (1)