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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00190788
First received: September 12, 2005
Last updated: October 10, 2007
Last verified: October 2007
  Purpose

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 a more rapid resolution of hypotension in severe septic patients.


Condition Intervention Phase
Sepsis
Hypotension
Drug: Drotrecogin Alfa (Activated)
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase IIIb Study to Determine Efficacy and Safety of Extended Drotrecogin Alfa (Activated) Therapy in Patients With Persistent Requirement for Vasopressor Support After 96 Hour Infusion With Commercial Drotrecogin Alfa (Activated)

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • - To assess whether continued administration of Drotrecogin Alfa (Activated)for up to 72 additional hours after 96 hours infusion of commercial DDA results in more rapid resolution of vasopressor-dependent hypotension

Secondary Outcome Measures:
  • Evaluate Reduction of 28-day all cause mortality
  • Evaluate effects on various organ functions over 14 days
  • Evaluate effects on the concentration of various biomarkers
  • Investigate safety profile of an extended infusion of DDA

Estimated Enrollment: 200
Study Start Date: June 2004
Study Completion Date: May 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00190788

Locations
United States, California
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
France
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
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00190788     History of Changes
Other Study ID Numbers: 6001, F1K-MC-EVBQ
Study First Received: September 12, 2005
Last Updated: October 10, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases
Drotrecogin alfa activated
Protein C
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 22, 2014