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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
Elgan Pharma Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intestinal Malabsorption

Eligibility Criteria

1 Day - 5 Days (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 2, 2023
    Last Updated
    October 3, 2023
    Sponsor
    Elgan Pharma Ltd.
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    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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