NCT01273779

Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis

OASIS: A Phase 2/3 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis

• Status: Suspended
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,280 (estimated)
• Sponsor: Agennix · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study will evaluate the safety and potential benefit of talactoferrin (recombinant human lactoferrin) as an addition to the standard care for severe sepsis.

Conditions

• Severe Sepsis

Interventions

Type	Name	Description
DRUG	Talactoferrin alfa	15 mL of an oral solution of 100mg/mL (1.5 g) given 3 times a day for up to 28 days or until discharge from the intensive care unit
DRUG	Placebo	15 mL of oral solution of placebo given 3 times a day for up to 28 days or until discharge from the intensive care unit

Timeline

• Start date: 2011-06-01
• Primary completion: 2014-01-01
• Completion: 2014-12-01
• First posted: 2011-01-11
• Last updated: 2012-02-03

Locations

100 sites across 10 countries: United States, Belgium, Canada, Denmark, France, Germany, Israel, Netherlands, Spain, United Kingdom