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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00084071
Enrollment
2136
Registered
2004-06-08
Start date
2004-05-31
Completion date
2008-07-31
Last updated
2020-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia

Brief 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.

Interventions

DRUGTifacogin

Sponsors

Novartis Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frame
Compare the effect of tifacogin vs placebo administration.

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026