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A Safety Evaluation of Drotrecogin Alfa (Activated) in Patients With Blood Cancer, Severe Infection Related to Bone Marrow Transplantation

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ClinicalTrials.gov Identifier: NCT00067730
Recruitment Status : Completed
First Posted : August 27, 2003
Last Update Posted : December 7, 2007
Sponsor:
Information provided by:
Eli Lilly and Company

Brief Summary:
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 or disease Intervention/treatment Phase
Sepsis Hematologic Neoplasms Hematopoietic Stem Cell Transplantation Infection Drug: Drotrecogin Alfa (activated) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Safety Evaluation of Xigris Drotrecogin Alfa Activated in Hematopoietic Stem Cell Transplant Patients With Severe Sepsis
Study Start Date : March 2003
Actual Study Completion Date : October 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arm Intervention/treatment
Experimental: 1
24 microgram/kg/hr for 96 hours (+ or - 1 hour)
Drug: Drotrecogin Alfa (activated)
Other Names:
  • LY203638
  • Xigris




Primary Outcome Measures :
  1. Safety [ Time Frame: 10 months ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: 10 months ]
  2. Bleeding incidence [ Time Frame: 10 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00067730


Locations
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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
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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

Additional Information:
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ClinicalTrials.gov Identifier: NCT00067730     History of Changes
Other Study ID Numbers: 6416
F1K-US-EVCE
First Posted: August 27, 2003    Key Record Dates
Last Update Posted: December 7, 2007
Last Verified: December 2007
Additional relevant MeSH terms:
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Infection
Sepsis
Hematologic Neoplasms
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Neoplasms by Site
Neoplasms
Hematologic Diseases
Drotrecogin alfa activated
Protein C
Anti-Infective Agents
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action