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

Tracking Information

First Received Date ^ICMJE

August 25, 2003

Last Updated Date

December 3, 2007

Start Date ^ICMJE

March 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Safety [ Time Frame: 10 months ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00067730 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Mortality [ Time Frame: 10 months ]
Bleeding incidence [ Time Frame: 10 months ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Safety Evaluation of Xigris Drotrecogin Alfa Activated in Hematopoietic Stem Cell Transplant Patients With Severe Sepsis

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).

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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Sepsis
Hematologic Neoplasms
Hematopoietic Stem Cell Transplantation
Infection

Intervention ^ICMJE

Drug: Drotrecogin Alfa (activated)

Study Arms / Comparison Groups

Experimental: 24 microgram/kg/hr for 96 hours (+ or - 1 hour)

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00067730

Responsible Party

Study ID Numbers ^ICMJE

6416, F1K-US-EVCE

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

Eli Lilly and Company

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP