Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants
Primary Purpose
Intestinal Malabsorption
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ELGN-2112
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Intestinal Malabsorption
Eligibility Criteria
Inclusion Criteria: Male or female pre-term infant 26 and up to 32 weeks gestation. Gestational age matching (±2 weeks) between maternal dates and/or early antenatal ultrasound Birth weight ≥ 500g Singleton or twin birth Exclusion Criteria: -
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
ELGN-2112
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Numbers of days to achieve full enteral feeding
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05670951
Brief Title
Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
November 2031 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elgan Pharma Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study will evaluate the effect of ELGN-2112 on intestinal malabsorption in preterm infants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Malabsorption
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
360 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ELGN-2112
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ELGN-2112
Intervention Description
Human insulin [rDNA]
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Numbers of days to achieve full enteral feeding
Time Frame
28 days or discharge from hospital
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
5 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female pre-term infant 26 and up to 32 weeks gestation. Gestational age matching (±2 weeks) between maternal dates and/or early antenatal ultrasound
Birth weight ≥ 500g
Singleton or twin birth
Exclusion Criteria:
-
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants
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