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NCT00084071 Clinical Trial

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

Pneumonia Clinical Trial

Official title:
Tifacogin (Recombinant Tissue Factor Pathway Inhibitor) for the Treatment of Patients With Severe Community-Acquired Pneumonia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00084071
Other study ID # CTFP561A2308
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date May 2004
Est. completion date July 2008

Study information
Verified date July 2012
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether tifacogin is effective and safe in the treatment of patients with severe community-acquired pneumonia.

Recruitment information / eligibility
Status Completed
Enrollment 2136
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tifacogin

Locations
Country Name City State
Brazil Belgium Salvador BA

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  Chile,  France,  Germany,  Korea, Republic of,  Malaysia,  Netherlands,  New Zealand,  Peru,  Singapore,  South Africa,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Compare the effect of tifacogin vs placebo administration.
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