Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis

Summary

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

Timeline

Start

2011-06

Primary completion

2014-01

Completion

2014-12

Outcome

Missed primary endpoint

Stopped: “Data Safety Monitoring Board recommendation”

paper Twenty-eight-day mortality was higher in talactoferrin-treated patients although this difference was not statistically significant (24.8% vs 17.8% placebo; p = 0.117). PMID 26010687 ↗

paper CONCLUSIONS: Administration of oral talactoferrin was not associated with reduced 28-day mortality in patients with severe sepsis and may even be harmful. PMID 26010687 ↗

Publications

• Vincent JL, Marshall JC, Dellinger RP, Simonson SG, Guntupalli K, Levy MM, Singer M, Malik R; Oral tAlactoferrin in Severe sepsIS Study Investigators. Talactoferrin in Severe Sepsis: Results From the Phase II/III Oral tAlactoferrin in Severe sepsIS Trial. Crit Care Med. 2015 Sep;43(9):1832-8. doi: 10.1097/CCM.0000000000001090.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Talactoferrin alfa	Protein / enzyme biologic	1.5 g	Oral

Indications