A Prospective, Randomized, Double-Blind, Phase 3 Study Comparing rhBSSL and Placebo Added to Infant Formula or Pasteurized Breast Milk During 4 Weeks of Treatment in Preterm Infants Born Before Week 32 of Gestational Age

Trial Profile

A Prospective, Randomized, Double-Blind, Phase 3 Study Comparing rhBSSL and Placebo Added to Infant Formula or Pasteurized Breast Milk During 4 Weeks of Treatment in Preterm Infants Born Before Week 32 of Gestational Age

Discontinued
Phase of Trial: Phase III

Latest Information Update: 07 Aug 2017

At a glance

  • Drugs Bucelipase alfa (Primary)
  • Indications Malabsorption syndromes
  • Focus Registrational; Therapeutic Use
  • Acronyms LAIF
  • Sponsors Swedish Orphan Biovitrum
  • Most Recent Events

    • 31 Oct 2014 Status changed from active, no longer recruiting to discontinued according to ClinicalTrials.gov record.
    • 07 Jul 2014 Planned End Date changed from 1 Aug 2013 to 1 Jul 2013 as reported by ClinicalTrials.gov record.
    • 28 Mar 2014 New trial record
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