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Recruiting Phase 2 NCT05904626
NCT05904626 Assess the Safety of ELGN-2112 in Preterm Infants Born Under 26 Weeks GA and IUGR Infants Born 26-32 Weeks GA
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| NCT ID | NCT05904626 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Elgan Pharma Ltd. |
| Condition | Intestinal Malabsorption |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-10-28 |
| Primary Completion | 2027-06 |
Trial Parameters
Condition Intestinal Malabsorption
Sponsor Elgan Pharma Ltd.
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 60
Sex ALL
Min Age 1 Day
Max Age 5 Days
Start Date 2025-10-28
Completion 2027-06
Interventions
ELGN-2112Placebo
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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.
Eligibility 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
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