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Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis (OASIS)

A

Agennix

Status and phase

Suspended
Phase 3
Phase 2

Conditions

Severe Sepsis

Treatments

Drug: Talactoferrin alfa
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01273779
LF-0802

Details and patient eligibility

About

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

Enrollment

1,280 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

1,280 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Treatment:
Drug: Placebo
Talactoferrin alfa
Experimental group
Treatment:
Drug: Talactoferrin alfa

Trial contacts and locations

100

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Data sourced from clinicaltrials.gov

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