7 completed, 3 terminated, 1 withdrawn. 6 Phase 2, 4 Phase 3, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 6 | Completed 3, Terminated 2, Withdrawn 1 |
| Phase 3 | 4 | Completed 3, Withdrawn 1 |
| Phase 1 | 1 | Terminated 1 |
Follow ecallantide: new trials by email Literature Review of ecallantide trials Research Report on ecallantide
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 Ecallantide in Paediatric Patients With Acute Attacks of Hereditary Angioedema ecallantide - Hereditary Angioedema (HAE) | Phase 2 / Phase 3 | Withdrawn | Shire | 2012-06-01 | 2021-05-18 | |
| Evaluation of Ecallantide for Treatment of Angiotensin Converting Enzyme (ACE) Inhibitor Induced Angioedema ecallantide 60 mg, ecallantide 30 mg, ecallantide 10 mg - ACE Inhibitor Induced Angioedema | Phase 2 | Terminated | Shire | 79 | 2011-06-01 | 2021-06-11 |
| Observational Safety Study for KALBITOR (Ecallantide) in the Treatment of Acute Attacks of Hereditary Angioedema ecallantide - Hereditary Angioedema (HAE) | Completed | Shire | 81 | 2010-02-01 | 2021-06-08 | |
| Study to Assess the Safety and Tolerability of a Single Administration of FOV2302 (Ecallantide) in Patients With Macular Edema Associated With Central Retinal Vein Occlusion FOV2302 (Ecallantide) - Macular Edema, Central Retinal Vein Occlusion | Phase 1 | Terminated | Fovea Pharmaceuticals SA | 11 | 2009-09-01 | 2012-01-10 |
| Outcomes and Safety Trial Investigating Ecallantide's Effect on Reducing Surgical Blood Loss Volume in Subjects at High Risk of Bleeding Exposed to Cardio-pulmonary Bypass During Cardiac Surgery Ecallantide, Cyklokapron(R) - Bloodloss, Surgical Procedures, Operative | Phase 2 | Completed | Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | 243 | 2009-06-01 | 2015-08-10 |
| A Dose-ranging Safety and Efficacy Study of Ecallantide to Reduce Surgical Blood Loss Volume ecallantide, placebo - Bloodloss, Surgical Procedures, Operative | Phase 2 | Completed | Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | 276 | 2009-03-01 | 2015-08-11 |
| Efficacy Study of Recombinant Protein (Ecallantide) to Reduce Blood Loss During Primary Coronary Bypass Grafting or Valve Repair/Replacement Ecallantide, Placebo - Blood Loss, Surgical | Phase 2 | Terminated | Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | 75 | 2007-05-01 | 2019-06-25 |
| Efficacy Study of DX-88 (Ecallantide) to Treat Acute Attacks of Hereditary Angioedema (HAE) ecallantide, Phosphate Buffer Saline (PBS), pH 7.0 - Hereditary Angioedema (HAE) | Phase 3 | Completed | Shire | 96 | 2007-04-01 | 2021-06-08 |
| Safety and Efficacy Study of Repeated Doses of DX-88 (Ecallantide) to Treat Attacks of Hereditary Angioedema (HAE) ecallantide - Hereditary Angioedema (HAE) | Phase 3 | Completed | Shire | 147 | 2007-04-01 | 2021-06-08 |
| Efficacy and Safety Study of DX-88 to Treat Acute Attacks of Hereditary Angioedema (HAE) ecallantide, Phosphate Buffer Saline (PBS), - Hereditary Angioedema (HAE) | Phase 3 | Completed | Shire | 91 | 2005-12-31 | 2021-06-11 |
| EDEMA2: Evaluation of DX-88's Effect in Mitigating Angioedema DX-88 (ecallantide) - Hereditary Angioedema (HAE) | Phase 2 | Completed | Shire | 77 | 2003-11-01 | 2021-05-18 |
Angioedemas, Hereditary (6) · Blood Loss, Surgical (1) · Macular Edema (1) · Retinal Vein Occlusion (1)
Shire (7) · Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) (3) · Fovea Pharmaceuticals SA (1)
United States (8) · Canada (3) · Jordan (2) · France (1) · Germany (1) · Poland (1)
Alistair Wheeler, MD, MFPM (2) · Alain Gaudric, MD (1) · Andrew L Sternlicht, MD (1)
PMID 23878046, PMID 24712435, PMID 23548529, PMID 21130380, PMID 22765833, PMID 23548526, PMID 20818887, PMID 21724197, PMID 25182544