A Safety Evaluation of Xigris Drotrecogin Alfa Activated in Hematopoietic Stem Cell Transplant Patients With Severe Sepsis
18 Years
N/A
Both
Sepsis, Hematologic Neoplasms, Hematopoietic Stem Cell Transplantation, Infection
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 |
