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A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants

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Trial Profile

A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 11 Jun 2025

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At a glance

  • Drugs ELGN GI (Primary) ; ELGN GI (Primary)
  • Indications Gastrointestinal disorders; Malabsorption syndromes
  • Focus Registrational; Therapeutic Use
  • Acronyms FIT-PIV
  • Sponsors Elgan Pharma

Most Recent Events

  • 05 Jun 2025 According to an Elgan Pharma media release, first participating infants have been dosed in this study.
  • 28 May 2025 Planned End Date changed from 1 Nov 2031 to 1 May 2029.
  • 28 May 2025 Planned primary completion date changed from 1 Nov 2025 to 1 Nov 2027.

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