A research study to evaluate if ELGN-2112 is safe for the treatment of Intestinal Malabsorption in Preterm Infants

Phase 1

• Conditions: Intestinal Malabsorption in Preterm Infants; MedDRA version: 20.0Level: LLTClassification code 10032413Term: Other preterm infants, 750-999 gramsSystem Organ Class: 100000004868; MedDRA version: 20.0Level: LLTClassification code 10032407Term: Other preterm infants, 1,250-1,499 gramsSystem Organ Class: 100000004868; MedDRA version: 20.0Level: LLTClassification code 10032409Term: Other preterm infants, 1,750-1,999 gramsSystem Organ Class: 100000004868; MedDRA version: 20.0Level: LLTClassification code 10032411Term: Other preterm infants, 2,500+ gramsSystem Organ Class: 100000004868; MedDRA version: 20.0Level: LLTClassification code 10032415Term: Other preterm infants, unspecified {weight}System Organ Class: 100000004868; MedDRA version: 20.0Level: LLTClassification code 10032412Term: Other preterm infants, 500-749 gramsSystem Organ Class: 100000004868; MedDRA version: 20.0Level: LLTClassification code 10032406Term: Other preterm infants, 1,000-1,249 gramsSystem Organ Class: 100000004868; MedDRA version: 20.0Level: LLTClassification code 10032408Term: Other preterm infants, 1,500-1,749 gramsSystem Organ Class: 100000004868; MedDRA version: 20.0Level: LLTClassification code 10032410Term: Other preterm infants, 2,000-2,499 gramsSystem Organ Class: 100000004868

• Registration Number: EUCTR2022-004195-42-AT
• Lead Sponsor: ELGAN Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-03
• Last Update Posted: 27 November 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

1. Male or female pre-term infants 26 and up to 32 weeks gestation (32 weeks + 0 day maximum). Gestational age matching (±2 weeks) between maternal dates and/or early antenatal ultrasound*.
2. Birth weight = 500g.
3. Singleton, or twin birth.
4. Postnatal age up through and including Day 5 (up to 120 hours post birth).
5. Fraction of inspired oxygen = 0.60 at enrolment.
6. Infants must demonstrate cardiovascular stability at time of enrolment and would be considered unstable if they require blood pressure support via a central line.
7. Infant is able to tolerate enteral feed.
8. Infant is expected to wean off PN at the primary hospital.
9. Informed consent form (ICF) signed by parents or legal guardian.
10. In the Investigator’s opinion, the infant is able to comply with the study procedures and sufficiently stable to partake in the trial to completion.
* If both exist and difference > 2 weeks, based on early antenatal ultrasound
Are the trial subjects under 18? yes
Number of subjects for this age range: 360
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Infant is consuming more than 100 ml/kg/day enterally at study entry
2. Infant is not dependent on any parenteral amino acids/lipids as nutrition
3. Major congenital malformation (e.g., Infants with genetic, metabolic, and/or endocrine disorder diagnosed before enrolment).
4. Intra-uterine growth restriction (IUGR) defined as weight for gestational age less than the third percentile according to Fenton preterm growth chart (see Appendix D).
5. Confirmed necrotizing enterocolitis (NEC).1
6. Maternal diabetes (Type I/II or gestational) requiring insulin during pregnancy or in mothers past medical history.
7. suspected or confirmed Hyperinsulinemia requiring glucose administration of more than 12 mg/kg/min at randomization.
8. Any systemic insulin administration at randomization.
9. Never anything per os (NPO) until 120 hrs post-birth for any reason.
10. Heart and chest compression or any resuscitation drugs given to the infant during delivery.
11. Subjects at risk for significant GI complications such as twin-to-twin transfusion syndrome (TTTS) or monochorionic monoamniotic twins.
12. Participation in another interventional clinical study that may interfere with the primary and secondary outcomes of this trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified