Trials / Completed
CompletedNCT00630656
Safety and Efficacy Study of Recombinant Human Lactoferrin to Treat Severe Sepsis
A Phase 2 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 190 (actual)
- Sponsor
- Agennix · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Study will evaluate the safety and potential benefit of recombinant human talactoferrin as an addition to the standard care of severe sepsis.
Conditions
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 | Placebo given 3 times a day for up to 28 days or until discharge from the intensive care unit |
Timeline
- Start date
- 2008-04-01
- Primary completion
- 2009-08-01
- Completion
- 2010-02-01
- First posted
- 2008-03-07
- Last updated
- 2011-08-23
Locations
34 sites across 5 countries: United States, Canada, France, Germany, Spain
Source: ClinicalTrials.gov record NCT00630656. Inclusion in this directory is not an endorsement.