Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448864
Status:
TERMINATED
Last Update Posted:
2019-06-25
First Post:
2007-03-16
Brief Title:
Efficacy Study of Recombinant Protein Ecallantide to Reduce Blood Loss During Primary Coronary Bypass Grafting or Valve RepairReplacement
Sponsor:
Cubist Pharmaceuticals LLC a subsidiary of Merck Co Inc Rahway New Jersey USA
Organization:
Cubist Pharmaceuticals LLC a subsidiary of Merck Co Inc Rahway New Jersey USA
Study Overview
Official Title:
KALAHARI-1 Kallikrein Antagonist DX-88 Ecallantide Effect on Blood Loss Associated With Heart Surgery Requiring Institution of Bypass
Status:
TERMINATED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Experience gained from this study is sufficient to design and facilitate the follow-on study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
This was a Phase 2 randomized double-blind placebo-controlled multi-center study designed to assess the efficacy and safety of 2 dose levels of ecallantide compared to placebo in reducing chest tube drainage in participants requiring CPB for primary CABG single valve repair or single valve replacement Participants were randomized in a 332 ratio to ecallantide high-dose regimen maximum 91 mg ecallantide low-dose regimen maximum 15 mg or placebo Randomization was stratified by surgical procedure so that participants undergoing valve replacement would be evenly distributed across treatment arms Each participant received active drug or placebo administered in stages on the day of the surgical procedure after induction of anesthesia Day 1
Participants were screened up to 14 days prior to surgery Additional study procedures were conducted on Day -1 or 1 peri-operatively during the immediate postoperative period and on Days 2 4 and 7 or at the time of discharge from the hospital and between Days 28 and 43 follow-up
Participants were screened up to 14 days prior to surgery Additional study procedures were conducted on Day -1 or 1 peri-operatively during the immediate postoperative period and on Days 2 4 and 7 or at the time of discharge from the hospital and between Days 28 and 43 follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DX-8816 | OTHER | Cubist Study Number | None |