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Sponsored by: |
Eli Lilly and Company |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00803231 |
The transparency commission wishes that the laboratory Lilly France sets up a follow-up study describing the conditions of use of Xigris® in France.
The purpose of this study is to describe the characteristics of the treated patients, the conditions of drug use, in particular the conditions of treatment initiation and the clinical development of the patients during normal clinical practice, in particular rate and cause of mortality within one month.
Condition |
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Sepsis |
Study Type: | Observational |
Study Design: | Cohort |
Official Title: | Follow-up Data of Patients Treated With XIGRIS® DROTRECOGIN ALFA (ACTIVATED) in France |
Estimated Enrollment: | 800 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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Retrospective cohort
Patient treated with Xigris between January 2006 and November 2008.
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Prospective cohort
Patient treated with Xigris between November 2008 and November 2009.
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The objectives of the study as defined by the specific requirements of Transparency Commission are as follows:
To describe the characteristics of the patients treated with Xigris®
To determine the conditions of use of Xigris®
To describe the clinical evolution of the patients
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
All adult patients treated with Xigris® between January 1st, 2006 and August 31st 2008 in intensive care units in France will be enrolled retrospectively, whereas all adult patients treated with Xigris® between September 1st, 2008 and September 1st, 2009 will be enrolled prospectively.
Patients are eligible to be included in the study if they meet the following criteria
Contact: There may be multiple sites in this observational study 1-877-CTLILLY (1-877-285-4559) | 1-317-615-4559 |
France | |
For additional information regarding investigative sites for this study, 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. | Recruiting |
Suresnes, France | |
Contact: Eli Lilly |
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon- fri 9AM-5PM eastern time (UTC/GMT- 5 hours,EST) | Eli Lilly and Company |
Responsible Party: | Eli Lilly ( Chief Medical Officer ) |
Study ID Numbers: | 12401, F1K-FR-B009 |
Study First Received: | December 4, 2008 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00803231 History of Changes |
Health Authority: | France: French Data Protection Authority; France: Haute Autorité de Santé Transparency Commission |
Drotrecogin alfa activated Sepsis |