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Sponsored by: |
Eli Lilly and Company |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00067730 |
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 IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Safety Evaluation of Xigris Drotrecogin Alfa Activated in Hematopoietic Stem Cell Transplant Patients With Severe Sepsis |
Enrollment: | 7 |
Study Start Date: | March 2003 |
Study Completion Date: | October 2003 |
Arms | Assigned Interventions |
---|---|
1: Experimental
24 microgram/kg/hr for 96 hours (+ or - 1 hour)
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Drug: Drotrecogin Alfa (activated) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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. | |
Winston-Salem, 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. | |
Durham, North Carolina, United States |
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 |
Study ID Numbers: | 6416, F1K-US-EVCE |
Study First Received: | August 25, 2003 |
Last Updated: | December 3, 2007 |
ClinicalTrials.gov Identifier: | NCT00067730 |
Health Authority: | United States: Food and Drug Administration |
Systemic Inflammatory Response Syndrome Drotrecogin alfa activated Sepsis Protein C |
Hematologic Neoplasms Hematologic Diseases Inflammation |
Communicable Diseases Anti-Infective Agents Anticoagulants Molecular Mechanisms of Pharmacological Action Hematologic Agents Fibrinolytic Agents Cardiovascular Agents |
Infection Pharmacologic Actions Neoplasms Fibrin Modulating Agents Pathologic Processes Neoplasms by Site Therapeutic Uses |