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Tifacogin for the Treatment of Patients With Severe Community-Acquired Pneumonia

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: June 4, 2004
Last updated: July 12, 2012
Last verified: July 2012
The purpose of this study is to determine whether tifacogin is effective and safe in the treatment of patients with severe community-acquired pneumonia.

Condition Intervention Phase
Pneumonia Drug: Tifacogin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Tifacogin (Recombinant Tissue Factor Pathway Inhibitor) for the Treatment of Patients With Severe Community-Acquired Pneumonia

Resource links provided by NLM:

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Compare the effect of tifacogin vs placebo administration.

Enrollment: 2136
Study Start Date: May 2004
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of community-acquired pneumonia supported by additional clinical, radiological, and microbiological evidence
  • Pneumonia of sufficient severity to require ICU admission and management

Exclusion Criteria:

  • Pregnancy
  • Weight over 150 kg
  • Patients at increased risk of bleeding
  • Treatment with drotrecogin alfa or anticipated need for drotrecogin alfa
  • Treatment with heparin or anticipated need for heparin
  Contacts and Locations
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Please refer to this study by its identifier: NCT00084071

  Show 150 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Novartis
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00084071     History of Changes
Other Study ID Numbers: CTFP561A2308
Study First Received: June 4, 2004
Last Updated: July 12, 2012

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Lipoprotein-associated coagulation inhibitor
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Factor Xa Inhibitors
Antithrombins processed this record on August 17, 2017