Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants

NCT ID: NCT05670951

Last Updated: 2025-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-20

Study Completion Date

2029-05-31

Brief Summary

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The study will evaluate the effect of ELGN-2112 on intestinal malabsorption in preterm infants.

Detailed Description

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Conditions

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Intestinal Malabsorption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ELGN-2112

Group Type ACTIVE_COMPARATOR

ELGN-2112

Intervention Type DRUG

Human insulin \[rDNA\]

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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ELGN-2112

Human insulin \[rDNA\]

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

\-
Minimum Eligible Age

1 Day

Maximum Eligible Age

5 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Elgan Pharma Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Laniado Hospital

Netanya, , Israel

Site Status RECRUITING

Countries

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Israel

Facility Contacts

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Tilly Bernat

Role: primary

972-8609118

Other Identifiers

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FIT-PIV

Identifier Type: -

Identifier Source: org_study_id

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