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NCT05904626 | NOT YET RECRUITING | Intestinal Malabsorption

Assess the Safety of ELGN-2112 in Preterm Infants Born Under 26 Weeks GA and IUGR Infants Born 26-32 Weeks GA
Sponsor:

Elgan Pharma Ltd.

Brief Summary:

To compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA and IUGR infants\<3rd percentile\* born at 26-32 weeks GA.

Condition or disease

Intestinal Malabsorption

Intervention/treatment

ELGN-2112

Placebo

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 60 participants
Masking : QUADRUPLE
Primary Purpose : OTHER
Official Title : A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Basket Study to Assess the Safety of ELGN-2112 in Preterm Infants Born Under 26 Weeks GA and IUGR Infants Born 26-32 Weeks GA
Actual Study Start Date : 2025-05
Estimated Primary Completion Date : 2027-06
Estimated Study Completion Date : 2027-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 1 Day to 5 Days
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Male or female preterm infant born less than 26 weeks GA or Intra-Uterine Growth Restricted infants born between 26+0 to 31+6 GA.
  • * Birth weight ≥ 450g
  • * Singleton or twin birth
Exclusion Criteria
  • N/A
Assess the Safety of ELGN-2112 in Preterm Infants Born Under 26 Weeks GA and IUGR Infants Born 26-32 Weeks GA

Location Details

NCT05904626

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