A Safety Evaluation of Drotrecogin Alfa (Activated) in Patients With Blood Cancer, Severe Infection Related to Bone Marrow Transplantation
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00067730
First received: August 25, 2003
Last updated: December 3, 2007
Last verified: December 2007
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Purpose
The purpose is to determine how Drotrecogin Alfa (activated) will affect patients with blood cancers who develop severe sepsis within 60 days of starting chemotherapy in preparation for bone marrow transplant (BMT).
| Condition | Intervention | Phase |
|---|---|---|
|
Sepsis Hematologic Neoplasms Hematopoietic Stem Cell Transplantation Infection |
Drug: Drotrecogin Alfa (activated) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Safety Evaluation of Xigris Drotrecogin Alfa Activated in Hematopoietic Stem Cell Transplant Patients With Severe Sepsis |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Safety [ Time Frame: 10 months ]
Secondary Outcome Measures:
- Mortality [ Time Frame: 10 months ]
- Bleeding incidence [ Time Frame: 10 months ]
| Enrollment: | 7 |
| Study Start Date: | March 2003 |
| Study Completion Date: | October 2003 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
24 microgram/kg/hr for 96 hours (+ or - 1 hour)
|
Drug: Drotrecogin Alfa (activated)
Other Names:
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00067730
Locations
| United States, 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. | |
| Denver, Colorado, United States | |
| United States, 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. | |
| Iowa City, Iowa, United States | |
| United States, 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. | |
| Manhassaet, New York, United States | |
| United States, North Carolina | |
| 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, United States | |
| 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. | |
| Winston-Salem, North Carolina, United States | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00067730 History of Changes |
| Other Study ID Numbers: | 6416, F1K-US-EVCE |
| Study First Received: | August 25, 2003 |
| Last Updated: | December 3, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasms Sepsis Toxemia Hematologic Neoplasms Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Neoplasms by Site Hematologic 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 May 23, 2013