Pharmacogenomic Biomarker Study for Recombinant Human Activated Protein C Treatment in Severe Sepsis

Status unconfirmed

Conditions studied: Severe Sepsis, Septic Shock

In brief

The overall purpose of the study is to determine whether either of the Improved Response Polymorphisms (IRPs) individually predicts a differential DrotAA treatment effect in patients with severe sepsis and high risk of death. This will be an international, multicenter, "prospective-retrospective", nonrandomized, controlled, outcome-blinded, genotype-blinded, matched-patients study. No prospective enrollment or treatment of patients will occur under this protocol. Retrospectively collected clinical data and DNA samples will be analyzed for existing cohorts of patients with severe sepsis who were previously treated with DrotAA (treatment group) or not (control group) as part of their standard care in an ICU.

Key facts

Study ID

NCT01486524

Run by

Sirius Genomics Inc.

People needed

3000

Starts

2011-10-01

Expected to finish

2012-04-01

Last updated by the study team

2011-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients with no DNA
• Patients enrolled in local cohort more than 2 years before Xigris [drotrecogin alfa activated)] was commercially available
• A secondary analysis population with severe sepsis will be defined by Inclusion Criteria 1, 2, 4, and 5 above, and the Exclusion Criteria. This will be referred to as the SEVSEP population.

Where it is running

• Emory University School of Medicine — Atlanta, Georgia, United States
• Johns Hopkins University, Bayview Medical Center — Baltimore, Maryland, United States
• Harvard University School of Public Health — Boston, Massachusetts, United States
• Vanderbilt University Schoo of Medicine — Nashville, Tennessee, United States
• University of British Columbia and Providence Health Care, St. Paul's Hospital — Vancouver, British Columbia, Canada
• University of Versailles, Hospital Raymond Poincaré (AP-HP) — Garches, France
• Université Paris Descartes, Sorbonne Paris Cité, Cochin Hotel-Dieu University Hospital — Paris, France
• Imperial College London, Charing Cross Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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