FIT-PIV Protocol V2.5 dated 31May2023
Research type
Research Study
Full 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.
IRAS ID
1007828
Contact name
Miki Olshansky
Contact email
Sponsor organisation
Elgan Pharma
Eudract number
2021-004890-29
Clinicaltrials.gov Identifier
Research summary
The study will evaluate the efficacy (how well it works) and safety of ELGN-2112 on intestinal malabsorption in babies born prematurely as compared to placebo (a substance that has no therapeutic effect, used as a control in testing new drugs).
ELGN-2112 is a powder for reconstitution (the process of restoring something dried to its original state) containing human recombinant insulin, mixed with either breast milk, infant formula, water, or normal and half-normal saline, and administered in a mixture with the baby's enteral (delivered through a tube to the stomach or the small intestine) nutrition for local gastrointestinal (GI) therapy.
The study will enroll babies born prematurely weighing at least 500 g and born between 26 and up to 32 weeks of pregnancy and who meet the inclusion and exclusion criteria. A normal pregnancy can range from 38 to 42 weeks. Infants born before 37 weeks are considered premature.
The effect on intestinal malabsorption will be evaluated by comparing the ability of enrolled babies to achieve full enteral (delivered through a tube to the stomach or the small intestine) feeding for three consecutive days.
Infants will be treated for 28 days or up to hospital discharge, whichever is the earliest. Enrolled babies will receive ELGN-2112 treatment or according to their recorded weight (0.3 IU/kg/day, where IU = International Units) or placebo. During the treatment period, babies will undergo daily evaluation of Adverse Events, concomitant (ongoing) medication, nutrition, general growth, and development progression. Babies will be evaluated at day of discharge. Follow-up visits will be performed at 3 or 6 months, 12 months, 24 months corrected age and 6 years.REC name
Wales REC 5
REC reference
24/WA/0014
Date of REC Opinion
11 Apr 2024
REC opinion
Further Information Favourable Opinion