- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00067730
A Safety Evaluation of Drotrecogin Alfa (Activated) in Patients With Blood Cancer, Severe Infection Related to Bone Marrow Transplantation
December 3, 2007 updated by: Eli Lilly and Company
A Safety Evaluation of Xigris Drotrecogin Alfa Activated in Hematopoietic Stem Cell Transplant Patients With Severe Sepsis
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).
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Denver, Colorado, 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.
-
-
Iowa
-
Iowa City, Iowa, 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.
-
-
New York
-
Manhassaet, New York, 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.
-
-
North Carolina
-
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
- 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.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
24 microgram/kg/hr for 96 hours (+ or - 1 hour)
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety
Time Frame: 10 months
|
10 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mortality
Time Frame: 10 months
|
10 months
|
Bleeding incidence
Time Frame: 10 months
|
10 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2003
Study Completion (Actual)
October 1, 2003
Study Registration Dates
First Submitted
August 25, 2003
First Submitted That Met QC Criteria
August 26, 2003
First Posted (Estimate)
August 27, 2003
Study Record Updates
Last Update Posted (Estimate)
December 7, 2007
Last Update Submitted That Met QC Criteria
December 3, 2007
Last Verified
December 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6416
- F1K-US-EVCE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sepsis
-
University of Kansas Medical CenterUniversity of KansasRecruitingSepsis | Septic Shock | Sepsis Syndrome | Sepsis, Severe | Sepsis Bacterial | Sepsis BacteremiaUnited States
-
Jip GroenInBiomeRecruitingMicrobial Colonization | Neonatal Infection | Neonatal Sepsis, Early-Onset | Microbial Disease | Clinical Sepsis | Culture Negative Neonatal Sepsis | Neonatal Sepsis, Late-Onset | Culture Positive Neonatal SepsisNetherlands
-
The University of QueenslandRoyal Brisbane and Women's HospitalUnknown
-
Karolinska InstitutetÖrebro University, SwedenCompletedSepsis | Sepsis Syndrome | Sepsis, SevereSweden
-
Ohio State UniversityCompletedSepsis, Severe Sepsis and Septic ShockUnited States
-
Indonesia UniversityCompletedSevere Sepsis With Septic Shock | Severe Sepsis Without Septic ShockIndonesia
-
University of LeicesterUniversity Hospitals, Leicester; The Royal College of AnaesthetistsCompletedSepsis | Septic Shock | Severe Sepsis | Sepsis SyndromeUnited Kingdom
-
Beckman Coulter, Inc.Biomedical Advanced Research and Development AuthorityRecruitingSevere Sepsis | Severe Sepsis Without Septic ShockUnited States
-
Weill Medical College of Cornell UniversityNational Heart, Lung, and Blood Institute (NHLBI); New York Presbyterian Hospital and other collaboratorsCompletedSepsis | Septic Shock | Severe Sepsis | Infection | Sepsis SyndromeUnited States
-
Inverness Medical InnovationsCompletedSepsis | Systemic Inflammatory Response Syndrome | Severe Sepsis | Sepsis SyndromeUnited States
Clinical Trials on Drotrecogin Alfa (activated)
-
Eli Lilly and CompanyCompleted
-
Eli Lilly and CompanyCompletedSepsisUnited States, Canada, Brazil, Mexico, Australia, Czech Republic, Slovakia, Spain, Austria, Belgium, Chile, Denmark, Egypt, Finland, France, Germany, India, Italy, Lebanon, Netherlands, New Zealand, Norway, Romania, Russian Federation, Saudi... and more
-
Eli Lilly and CompanyCompletedSepsis | Septic ShockUnited States
-
Eli Lilly and CompanyCompletedSepsisUnited States, United Kingdom, France, Slovakia, Switzerland, Australia, Poland, Italy, Chile, Germany, Mexico
-
Eli Lilly and CompanyCompletedSepsisItaly, United Kingdom, United States, Germany, Spain, Belgium, France, Australia, Czech Republic, Netherlands, Canada, Mexico, New Zealand, Finland, Portugal, Brazil, India, Switzerland
-
Eli Lilly and CompanyCompletedSepsis | HypotensionFrance, United States
-
Eli Lilly and CompanyCompletedSevere SepsisUnited States, Belgium, Spain, France, Finland, Germany, Canada, United Kingdom, Puerto Rico
-
George Washington UniversityEli Lilly and CompanyCompletedEnd Stage Renal DiseaseUnited States
-
Eli Lilly and CompanyCompletedSepsisCanada, Finland, Belgium, Argentina, Chile, Australia, Austria, Brazil, Czech Republic, Denmark, Egypt, France
-
Eli Lilly and CompanyCompletedSubmassive Pulmonary EmbolismGermany