Status:

COMPLETED

Extended Therapy of Drotrecogin Alfa (Activated) 4 vs 7 Days Infusion

Lead Sponsor:

Eli Lilly and Company

Conditions:

Sepsis

Hypotension

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

The purpose of this study is to determine whether continued administration of Drotrecogin Alfa (Activated) up to additional 72 hours - after the so far recommended 96 hour infusion period - results in...

Eligibility Criteria

Inclusion

  • Severe sepsis patients treated with 96 hour infusion of commercial Drotrecogin Alfa (Activated)
  • Continue requirement of Vasopressor support after 96 hour commercial infusion

Exclusion

  • Patients require extensive surgical procedures within next 3 days
  • Patients with platelet count below 30,000/mm3
  • Patients receiving therapeutic heparin of 15,000 units/day and more
  • Patients not expected to survive 24 days
  • Patients contraindicated as to the country specific registration

Key Trial Info

Start Date :

June 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 1 2007

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT00190788

Start Date

June 1 2004

End Date

May 1 2007

Last Update

October 12 2007

Active Locations (2)

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Page 1 of 1 (2 locations)

1

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Loma Linda, California, United States, 92350

2

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Paris, France, 75679