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Efficacy Study of Recombinant Protein (Ecallantide) to Reduce Blood Loss During Primary Coronary Bypass Grafting or Valve Repair/Replacement
Phase 2 trial testing Ecallantide in Blood Loss, Surgical in 75 participants. Terminated before completion.
| Lead sponsor | Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 75 |
| Start date | 1 May 2007 |
| Primary completion | 1 July 2008 |
| Estimated completion | 1 August 2008 |
| Sites | 15 locations across United States |
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) — full company profile →
Adults 18 to 85, any sex, with Blood Loss, Surgical. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mean volume of chest tube drainage during the first 12 hours postoperatively or until chest tube removal, whichever occurred first, is presented for each treatment group.
| Group | Value | 95% CI |
|---|---|---|
| Ecallantide - Low Dose Regimen | 729.9 | ± 432.03 |
| Ecallantide - High Dose Regimen | 935.8 | ± 510.18 |
| Placebo | 1400.7 | ± 1371.65 |
Mean volume of chest tube drainage during the first 24 hours postoperatively or until chest tube removal, whichever occurred first, is presented for each treatment group.
| Group | Value | 95% CI |
|---|---|---|
| Ecallantide - Low Dose Regimen | 82.9 | ± 74.99 |
| Ecallantide - High Dose Regimen | 149.8 | ± 132.27 |
| Placebo | 225.3 | ± 453.60 |
A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
| Group | Value | 95% CI |
|---|---|---|
| Ecallantide - Low Dose Regimen | 25 | |
| Ecallantide - High Dose Regimen | 23 | |
| Placebo | 18 |
Results are reported in terms of the Area Under Plasma Concentration Time Curve (AUC), measured as milligram hour per liter (mg\*h/L)
| Group | Value | 95% CI |
|---|---|---|
| Ecallantide - Low Dose Regimen | 1.39 | ± 0.589 |
| Ecallantide - High Dose Regimen | 13.6 | ± 3.58 |
Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Ecallantide - Low Dose Reg… | Ecallantide - High Dose Re… | Placebo |
|---|---|---|---|---|
| Haemorrhage | Vascular disorders | — | — | — |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | — | — | — |
| Coagulopathy | Blood and lymphatic system disorders | — | — | — |
| Arrhythmia supraventricular | Cardiac disorders | — | — | — |
| Cardiac failure congestive | Cardiac disorders | — | — | — |
| Myocardial infarction | Cardiac disorders | — | — | — |
| Ventricular tachycardia | Cardiac disorders | — | — | — |
| Ileus | Gastrointestinal disorders | — | — | — |
| Multi-organ failure | General disorders | — | — | — |
| Infection | Infections and infestations | — | — | — |
| Wound infection | Infections and infestations | — | — | — |
| Transfusion reaction | Injury, poisoning and procedural complications | — | — | — |
| International normalised ratio increased | Investigations | — | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — | — |
| Hyperkalaemia | Metabolism and nutrition disorders | — | — | — |
| Cerebral infarction | Nervous system disorders | — | — | — |
| Convulsion | Nervous system disorders | — | — | — |
| Syncope | Nervous system disorders | — | — | — |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Haemodynamic instability | Vascular disorders | — | — | — |
| Venous thrombosis | Vascular disorders | — | — | — |
| Hypotension | Vascular disorders | — | — | — |
| Reaction | System | Ecallantide - Low Dose Reg… | Ecallantide - High Dose Re… | Placebo |
|---|---|---|---|---|
| Procedural pain | Injury, poisoning and procedural complications | — | — | — |
| Atrial fibrillation | Cardiac disorders | — | — | — |
| Hypotension | Vascular disorders | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Tachycardia | Cardiac disorders | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — |
| Pyrexia | General disorders | — | — | — |
| Incision site pain | Injury, poisoning and procedural complications | — | — | — |
| Post procedural oedema | Injury, poisoning and procedural complications | — | — | — |
| Hypertension | Vascular disorders | — | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — |
| Body temperature increased | Investigations | — | — | — |
| Cardiac enzymes increased | Investigations | — | — | — |
| Haemoglobin decreased | Investigations | — | — | — |
| Thoracic cavity drainage test abnormal | Investigations | — | — | — |
| Urine output decreased | Investigations | — | — | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — | — |
| Hypovolaemia | Metabolism and nutrition disorders | — | — | — |
| Dizziness | Nervous system disorders | — | — | — |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Leukocytosis | Blood and lymphatic system disorders | — | — | — |
| Arrhythmia | Cardiac disorders | — | — | — |
| Atrial flutter | Cardiac disorders | — | — | — |
| Bradycardia | Cardiac disorders | — | — | — |
| Pericarditis | Cardiac disorders | — | — | — |
| Supraventricular extrasystoles | Cardiac disorders | — | — | — |
| Supraventricular tachycardia | Cardiac disorders | — | — | — |
| Ventricular extrasystoles | Cardiac disorders | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — |
| Localised oedema | General disorders | — | — | — |
| Oedema | General disorders | — | — | — |
| Oedema peripheral | General disorders | — | — | — |
| Pain | General disorders | — | — | — |
| Anaemia postoperative | Injury, poisoning and procedural complications | — | — | — |
| Mean arterial pressure decreased | Investigations | — | — | — |
Most-reported serious reactions: Haemorrhage, Post procedural haemorrhage, Coagulopathy, Arrhythmia supraventricular, Cardiac failure congestive, Myocardial infarction, Ventricular tachycardia, Ileus.
Data from ClinicalTrials.gov NCT00448864 adverse events section.
The primary objective of this study was to assess the efficacy and safety of 2 dose levels of ecallantide versus placebo in reducing blood loss following cardiopulmonary bypass (CPB), as measured by chest tube drainage during the first 12 hours postoperatively or until the chest tube was removed, whichever came first, in patients undergoing primary coronary artery bypass grafting (CABG), single valve repair, or single valve replacement. The secondary objective was to compare the efficacy of all ecallantide-treated participants (pooled high and low-doses) to placebo and to compare the high-dose to the low-dose ecallantide group. Other secondary objectives were to evaluate pharmacokinetics and antibody formation.
No peer-reviewed publications indexed yet for this trial.
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