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A Safety Evaluation of Xigris Drotrecogin Alfa Activated in Hematopoietic Stem Cell Transplant Patients With Severe Sepsis


Phase 4
18 Years
N/A
Not Enrolling
Both
Sepsis, Hematologic Neoplasms, Hematopoietic Stem Cell Transplantation, Infection

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Trial Information

A Safety Evaluation of Xigris Drotrecogin Alfa Activated in Hematopoietic Stem Cell Transplant Patients With Severe Sepsis


The purpose of this study is to determine how Drotrecogin Alfa (activated) will affect
leukemia, lymphoma and myeloma patients who develop sever sepsis within 60 days of starting
chemotherapy in preparation for bone marrow transplant (BMT). The study will evaluate the
safety of Xigris by assessing the risk of serious bleeding events, including bleeding within
the brain and serious bleeding leading to death.


Inclusion Criteria:



- Participants must have Leukemia, Lymphoma or Myeloma.

- Participants must have had hematopoietic stem cell transplantation(HSCT) within the
past 60 days.

- Participants must have infection with either vasopressor dependent septic shock or
ventilator-dependent respiratory failure.

- Participants must be on a breathing machine or require medication to maintain their
blood pressure.

Exclusion Criteria:

- Participants must not have increased bleeding risk due to medical conditions or
medications.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety

Outcome Time Frame:

10 months

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

6416

NCT ID:

NCT00067730

Start Date:

March 2003

Completion Date:

October 2003

Related Keywords:

  • Sepsis
  • Hematologic Neoplasms
  • Hematopoietic Stem Cell Transplantation
  • Infection
  • Neoplasms
  • Sepsis
  • Toxemia
  • Hematologic Neoplasms

Name

Location

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.Denver, Colorado  
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.Iowa City, Iowa  
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.Manhassaet, New York  
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.Durham, North Carolina