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

Intestinal Malabsorption Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05670951
• Other study ID #: FIT-PIV
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: November 2023
• Est. completion date: November 2031

Study information

• Verified date: October 2023
• Source: Elgan Pharma Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: November 2031
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 5 Days

Eligibility

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: -

Related Conditions & MeSH terms

• Intestinal Malabsorption
• Malabsorption Syndromes

Intervention

Drug:
• ELGN-2112
Human insulin [rDNA]
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Elgan Pharma Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numbers of days to achieve full enteral feeding		28 days or discharge from hospital