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

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01273779

Acronym

OASIS

Enrollment

1280

Registered

2011-01-11

Start date

2011-06-30

Completion date

2014-12-31

Last updated

2012-02-03

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

Conditions

Severe Sepsis

Keywords

sepsis, talactoferrin, lactoferrin, recombinant human lactoferrin

Brief summary

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

Interventions

DRUGTalactoferrin 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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age greater than or equal to 18 years * Onset of severe sepsis within the previous 24 hours * Must be receiving antibiotic therapy * Informed consent form signed by patient or authorized representatives according to local rules or regulations * Able to take liquid medication by mouth or feeding tube

Exclusion criteria

* Receipt of investigational medication within 4 weeks prior to participation in the study * Pregnant or breast-feeding * Severe congestive heart failure * Known severe HIV infection * Presence of severe burns * Patients on high dose immunosuppressants * Patients whose death is considered imminent * Patients whose life expectancy for concurrent illness is less than 6 months * Severe hypoxic encephalopathy or persistent vegetative state * Severe liver disease * Chronically bed bound * Patient, legal representative or patient's primary physician not committed to providing full, aggressive life support

Design outcomes

Primary

Measure	Time frame
All Cause Mortality	28 Days

Secondary

Measure	Time frame
All Cause Mortality	3 months
Assess Safety and Tolerability	28 days

Countries

Belgium, Canada, Denmark, France, Germany, Israel, Netherlands, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026