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Efficacy Study of Recombinant Protein (Ecallantide) to Reduce Blood Loss During Primary Coronary Bypass Grafting or Valve Repair/Replacement

This study has been terminated.
(Experience gained from this study is sufficient to design and facilitate the follow-on study)
Sponsor:
Information provided by:
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00448864
First received: March 16, 2007
Last updated: September 9, 2008
Last verified: September 2008

March 16, 2007
September 9, 2008
April 2007
June 2008   (final data collection date for primary outcome measure)
Chest tube drainage during the first 12 hours postoperatively [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
Chest tube drainage during the first 12 hours postoperatively
Complete list of historical versions of study NCT00448864 on ClinicalTrials.gov Archive Site
  • Cumulative chest tube drainage at 24 hours postoperatively or until chest tube removal [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Safety and tolerability of DX-88 (ecallantide) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics of DX-88 (ecallantide) [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Cumulative chest tube drainage at 24 hours postoperatively or until chest tube removal
  • Safety and tolerability of DX-88 (ecallantide)
  • Pharmacokinetics of DX-88 (ecallantide)
Not Provided
Not Provided
 
Efficacy Study of Recombinant Protein (Ecallantide) to Reduce Blood Loss During Primary Coronary Bypass Grafting or Valve Repair/Replacement
DX-88 (Ecallantide) for the Reduction of Blood Loss Associated With Cardiopulmonary Bypass: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study in Patients Undergoing Primary Coronary Artery Bypass Grafting, Single Valve Repair or Single Valve Replacement

The purpose of this study is to evaluate two different dose regimens of ecallantide to determine whether either or both dose regimens reduce blood loss, measured by chest tube drainage, compared to placebo during cardiopulmonary bypass surgery.

This is a placebo-controlled trial. Patients are randomized to intravenous administration of high dose ecallantide, low dose ecallantide, or placebo.

The study is designed to evaluate the potential for transfusion reduction in patients receiving ecallantide undergoing cardiopulmonary bypass during primary coronary bypass graft, isolated valve repair, or isolated valve replacement surgery by measuring thoracic drainage. This study is designed to provide data determining the effect of kallikrein inhibition or kallikrein plus plasmin inhibition, compared to placebo, in reducing chest tube drainage. These data are anticipated to support the dose selection in subsequent larger studies to demonstrate the safety and efficacy of ecallantide. Efficacy, safety and pharmacokinetics of ecallantide will be evaluated in this study.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Blood Loss, Surgical
  • Drug: ecallantide
    solution for IV infusion over the duration of the surgical procedure
    Other Name: DX-88
  • Drug: placebo
    solution for IV infusion over the duration of the surgical procedure
  • Experimental: 1
    DX-88 (ecallantide) - low dose regimen
    Intervention: Drug: ecallantide
  • Experimental: 2
    DX-88 (ecallantide) - high dose regimen
    Intervention: Drug: ecallantide
  • Placebo Comparator: 3
    Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
160
August 2008
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men and women age 18 to 79
  • Elective primary CABG, single valve repair, or single valve replacement requiring CPB and sternotomy
  • No plan to use desmopressin acetate (DDAVP), atrial natriuretic hormone, EACA, tranexamic acid or aprotinin during or postoperatively
  • Female patients must be non-lactating and not pregnant
  • If of childbearing potential, female patients must agree to use adequate contraception for 1 month after receiving study drug

Exclusion Criteria:

  • Concomitant surgery
  • Planned hypothermic CPB using temperatures less than 28C
  • Weight < 55 kg
  • Major end organ dysfunction
  • Serious intercurrent illness or active infection
  • Previous exposure to DX-88 (ecallantide)
  • Known allergy to ecallantide or any of its components, fentanyl, midazolam, isoflurane, propofol, morphine, heparin or protamine
  • Autologous blood donation ≤ 30 days month prior to surgery
  • Known substance abuse
  • Receipt of an investigational drug or device within 30 days prior to surgery
  • Administration prior to surgery of Eptifibatide, Tirofiban HCl, enoxaparin sodium or other low molecular weight heparin, Clopidogrel, Warfarin, Ticlopidine, Abciximab
Both
18 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00448864
DX-88/16
Yes
Ed Campanaro, Cubist Pharmaceuticals
Cubist Pharmaceuticals
Not Provided
Study Director: Andrew L Sternlicht, MD Dyax Corp.
Cubist Pharmaceuticals
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP