search
Back to results

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

Primary Purpose

Intestinal Malabsorption

Status
Not yet recruiting
Phase
Phase 2
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 other trial for Intestinal Malabsorption

Eligibility Criteria

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

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    ELGN-2112 Human insulin [rDNA]

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA
    Safety will be assessed by capturing of adverse events (AEs) during the treatment period.
    Compare the safety of treatment with ELGN-2112 to placebo in preterm infants born IUGR infants<3rd percentile* born at 26-32 weeks GA.
    Safety will be assessed by capturing of adverse events (AEs) during the treatment period.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 30, 2023
    Last Updated
    June 12, 2023
    Sponsor
    Elgan Pharma Ltd.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05904626
    Brief Title
    Assess the Safety of ELGN-2112 in Preterm Infants Born Under 26 Weeks GA and IUGR Infants Born 26-32 Weeks GA
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    September 2025 (Anticipated)
    Study Completion Date
    September 2025 (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
    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.

    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
    Other
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ELGN-2112 Human insulin [rDNA]
    Arm Type
    Active Comparator
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    ELGN-2112
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    A placebo formulation consisting of the same inactive ingredients as ELGN-2112.
    Primary Outcome Measure Information:
    Title
    Compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA
    Description
    Safety will be assessed by capturing of adverse events (AEs) during the treatment period.
    Time Frame
    Five days from birth until 42 days
    Title
    Compare the safety of treatment with ELGN-2112 to placebo in preterm infants born IUGR infants<3rd percentile* born at 26-32 weeks GA.
    Description
    Safety will be assessed by capturing of adverse events (AEs) during the treatment period.
    Time Frame
    Five days from birth until 42 days

    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 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Miki Olshansky
    Phone
    972-4-6098626
    Email
    CA@elganpharma.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Miki Olshansky
    Organizational Affiliation
    Elgan Pharma Ltd.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs