Drotrecogin alfa

Generic Name: Drotrecogin alfa

Drug Type: Biotech

CAS Number: 98530-76-8

Unique Ingredient Identifier: JGH8MYC891

Background: Drotrecogin alfa is activated human protein C that is synthesized by recombinant DNA technology. It is a glycoprotein of approximately 55 kilodalton molecular weight, consisting of a heavy chain and a light chain linked by a disulfide bond. Drotrecogin alfa was withdrawn from the market after a major study indicated that it was not effective in improving outcomes in patients with sepsis.

Indication: For reduction of mortality in patients with severe sepsis.

Clinical Trials

Modulation of Vasoreactivity in Septic Shock: Impact of Recombinant Protein C

Phase 4

Completed

Conditions: Septic Shock

Interventions: Drug: Recombinant Activated Protein C
Device: Near-infrared spectroscopy (NIRS)
Drug: Phenylephrine
Biological: Blood sample

First Posted Date: 2016-08-31

Last Posted Date: 2016-08-31

Lead Sponsor: Central Hospital, Nancy, France

Target Recruit Count: 30

Registration Number: NCT02885168

Regression Discontinuity Design to Evaluate of Drotrecogin Alpha Effectiveness

Completed

Conditions: Sepsis

First Posted Date: 2016-07-26

Last Posted Date: 2016-07-26

Lead Sponsor: Boston Medical Center

Target Recruit Count: 12492

Registration Number: NCT02843685

Locations: 🇺🇸
Boston Medical Center, Boston, Massachusetts, United States

Administration of Human Protein C Concentrates in Patients With Sepsis and Septic Shock.

Phase 2

Completed

Conditions: Sepsis
Septic Shock

Interventions: Drug: Placebo comparator
Drug: Human protein C concentrate
Drug: Activated protein C

First Posted Date: 2011-08-08

Last Posted Date: 2015-12-02

Lead Sponsor: University of Roma La Sapienza

Target Recruit Count: 60

Registration Number: NCT01411670

Locations: 🇮🇹
Departement of Anesthesiology and Intensive Care of the University of Rome La Sapienza, Rome, Italy

Activated Protein C in Severe Acute Pancreatitis

Phase 4

Completed

Conditions: Acute Pancreatitis

Interventions: Drug: Activated protein C

First Posted Date: 2009-11-20

Last Posted Date: 2010-10-14

Lead Sponsor: Helsinki University Central Hospital

Target Recruit Count: 32

Registration Number: NCT01017107

Locations: 🇫🇮
Helsinki University Central Hospital, Helsinki, Finland

Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients With Septic Shock

Phase 3

Completed

Conditions: Sepsis

Interventions: Drug: Placebo
Drug: Drotrecogin alfa (activated)

First Posted Date: 2008-01-30

Last Posted Date: 2012-09-18

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 1696

Registration Number: NCT00604214

Locations: 🇬🇧
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., London, United Kingdom

An Open Label Study of Severe Sepsis in Adults

Phase 4

Completed

Conditions: Severe Sepsis

Interventions: Drug: drotrecogin alfa (activated)

First Posted Date: 2007-12-06

Last Posted Date: 2007-12-06

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 130

Registration Number: NCT00568893

Locations: 🇧🇪
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., Wilrijk, Belgium

The Study of Drotrecogin Alfa (Activated) in Adult Patients With Severe Sepsis at a Low Risk of Death

Phase 3

Completed

Conditions: Sepsis

Interventions: Drug: Placebo
Drug: Drotrecogin alfa (activated)

First Posted Date: 2007-12-06

Last Posted Date: 2007-12-06

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 2640

Registration Number: NCT00568737

Locations: 🇫🇷
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., Gleize, France

Activated Protein C in Acute Stroke Trial

Phase 2

Terminated

Conditions: Stroke

Interventions: Drug: Activated Protein C

First Posted Date: 2007-09-21

Last Posted Date: 2016-10-24

Lead Sponsor: University of Rochester

Target Recruit Count: 12

Registration Number: NCT00533546

Locations: 🇺🇸
Loyola University Medical Center, Maywood, Illinois, United States
🇺🇸
Maimonides Medical Center, Brooklyn, New York, United States
🇺🇸
Rochester General Hospital, Rochester, New York, United States

and more 6 locations

Evaluate Protein C Levels in Severe Sepsis Patients on Drotrecogin Alfa (Activated)

Phase 2

Completed

Conditions: Severe Sepsis

Interventions: Drug: Drotrecogin alfa (activated)

First Posted Date: 2006-10-11

Last Posted Date: 2010-12-16

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 486

Registration Number: NCT00386425

Locations: 🇬🇧
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., Birmingham, West Midlands, United Kingdom

Hemodynamic and Perfusion Response to Drotrecogin Alfa (Activated) in Patients With Septic Shock

Phase 4

Completed

Conditions: Sepsis
Septic Shock

First Posted Date: 2006-01-19

Last Posted Date: 2009-09-02

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 43

Registration Number: NCT00279214

Locations: 🇺🇸
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., Akron, Ohio, United States

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