NCT00067730

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sepsis
• Hematologic Neoplasms
• Hematopoietic Stem Cell Transplantation
• Infection

Interventions

Type	Name	Description
DRUG	Drotrecogin Alfa (activated)

Timeline

• Start date: 2003-03-01
• Completion: 2003-10-01
• First posted: 2003-08-27
• Last updated: 2007-12-07

Locations

5 sites across 1 country: United States