A Phase 3 interventional study of NTRA-2112 and Placebo in Premature Birth of Newborn and Intestinal Malabsorption, sponsored by Elgan Pharma Ltd.. Terminated at 50 sites in 10 countries. Open to participants aged 1 Day to 5 Days. Per ClinicalTrials.gov, last updated 2025-08-19.
Sponsored by Elgan Pharma Ltd. · Phase 3, Interventional, and Treatment
The study will evaluate the effect of NTRA-2112 on intestinal malabsorption in preterm infants.
The study will assess the efficacy and safety of NTRA-2112 on intestinal malabsorption in preterm infants as compared to placebo
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's enrollment of 300 is above the median of 84 across 1,666 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Elgan Pharma Ltd. is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
1. Complete enteral feeding
NTRA-2112 A - Dose 1 To be administered orally with daily feed for 28 days or until discharge from hospital.
Drug: NTRA-2112
NTRA-2112 B - Dose 2 To be administered orally with daily feed for 28 days or until discharge from hospital.
Drug: NTRA-2112
Placebo To be administered orally with daily feed for 28 days or until discharge from hospital.
Drug: Placebo
Numbers of Days to Achieve Complete Enteral Feeding
Numbers of days to achieve full enteral feeding (NFE) is defined as: Number of Days to the first day of achieving enteral feeding of at least 150 ml/kg/day, which must be sustained for at least 3 consecutive days.
Time frame: 28 days or discharge from hospital
Number of Days to Achieve Discharge From Hospital or Readiness to Discharge
Readiness for discharge from hospital is defined as achieving all of the below: * Infant weight ≥ 1800g * Stable body temperature * Capable of oral feeding (reached full enteral feeding and not dependent on PN)
Time frame: 28 days or discharge from hospital
| Milestone | NTRA-2112 A | NTRA-2112 B | Placebo |
|---|---|---|---|
| Started | 108 | 94 | 98 |
| Completed | 77 | 72 | 76 |
| Not completed | 31 | 22 | 22 |
| Withdrew: Discontinued from treatment | 27 | 18 | 19 |
| Withdrew: Other | 4 | 4 | 3 |
Numbers of days to achieve full enteral feeding (NFE) is defined as: Number of Days to the first day of achieving enteral feeding of at least 150 ml/kg/day, which must be sustained for at least 3 consecutive days.
| Days | NTRA-2112 A | NTRA-2112 B | Placebo |
|---|---|---|---|
| Numbers of Days to Achieve Complete Enteral Feeding | 9.3 ± 4.81 | 10.0 ± 6.09 | 10.3 ± 5.10 |
Readiness for discharge from hospital is defined as achieving all of the below: * Infant weight ≥ 1800g * Stable body temperature * Capable of oral feeding (reached full enteral feeding and not dependent on PN)
| Days | NTRA-2112 A | NTRA-2112 B | Placebo |
|---|---|---|---|
| Number of Days to Achieve Discharge From Hospital or Readiness to Discharge | 36.4 ± 16.26 | 33.8 ± 14.36 | 36 ± 15.21 |
Collected over 18 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NTRA-2112 A | 5/108 (4.6%) | 15/108 (13.9%) | 91/108 (84.3%) |
| NTRA-2112 B | 1/88 (1.1%) | 10/88 (11.4%) | 70/88 (79.5%) |
| Placebo | 4/97 (4.1%) | 19/97 (19.6%) | 81/97 (83.5%) |
| Event | NTRA-2112 A | NTRA-2112 B | Placebo |
|---|---|---|---|
| Necrotising enterocolitis neonatalGastrointestinal disorders | 7/108 | 3/88 | 8/97 |
| Sepsis neonatalInfections and infestations | 4/108 | 2/88 | 5/97 |
| Patent ductus arteriosusCongenital, familial and genetic disorders | 1/108 | 3/88 | 1/97 |
| Necrotising colitisGastrointestinal disorders | 0/108 | 1/88 | 3/97 |
| Neonatal pneumoniaInfections and infestations | 0/108 | 0/88 | 2/97 |
| Intestinal perforationGastrointestinal disorders | 0/108 | 1/88 | 0/97 |
| HypoglycaemiaMetabolism and nutrition disorders | 0/108 | 1/88 | 0/97 |
| Hypoglycaemia neonatalMetabolism and nutrition disorders | 0/108 | 1/88 | 0/97 |
| Renal failureRenal and urinary disorders | 0/108 | 1/88 | 0/97 |
| Neonatal respiratory acidosisRespiratory, thoracic and mediastinal disorders | 0/108 | 1/88 | 1/97 |
| Event | NTRA-2112 A | NTRA-2112 B | Placebo |
|---|---|---|---|
| Anaemia neonatalBlood and lymphatic system disorders | 39/108 | 34/88 | 34/97 |
| Infantile apnoeaRespiratory, thoracic and mediastinal disorders | 20/108 | 12/88 | 16/97 |
| AnaemiaBlood and lymphatic system disorders | 18/108 | 14/88 | 13/97 |
| patent ductus arteriosisCongenital, familial and genetic disorders | 12/108 | 9/88 | 9/97 |
| Neonatal hyponatraemiaMetabolism and nutrition disorders | 12/108 | 8/88 | 8/97 |
| Ophthalmia neonatorumInfections and infestations | 4/108 | 6/88 | 10/97 |
| Sepsis neonatalInfections and infestations | 9/108 | 6/88 | 8/97 |
| Bronchopulmonary dysplasiaRespiratory, thoracic and mediastinal disorders | 9/108 | 6/88 | 2/97 |
| Necrotising enterocolitis neonatalGastrointestinal disorders | 7/108 | 3/88 | 8/97 |
| Neonatal respiratory failureRespiratory, thoracic and mediastinal disorders | 7/108 | 3/88 | 3/97 |
Due to early study termination by the Sponsor, only 300 of the 450 intended subjects were enrolled.
| Age, Customized(Participants) | NTRA-2112 A | NTRA-2112 B | Placebo | Total |
|---|---|---|---|---|
| 26-28 weeks | 49 | 46 | 51 | 146 |
| 29-32 weeks | 58 | 48 | 47 | 153 |
| Sex: Female, Male(Participants) | NTRA-2112 A | NTRA-2112 B | Placebo | Total |
|---|---|---|---|---|
| Female | 64 | 51 | 54 | 169 |
| Male | 44 | 43 | 44 | 131 |
| Race (NIH/OMB)(Participants) | NTRA-2112 A | NTRA-2112 B | Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 6 | 5 | 6 | 17 |
| White | 78 | 72 | 69 | 219 |
| More than one race | 24 | 17 | 22 | 63 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | NTRA-2112 A | NTRA-2112 B | Placebo | Total |
|---|---|---|---|---|
| Netherlands | 25 | 24 | 25 | 74 |
| Belgium | 14 | 5 | 8 | 27 |
| Hungary | 7 | 6 | 5 | 18 |
| United States | 6 | 5 | 5 | 16 |
| Italy | 15 | 13 | 15 | 43 |
| United Kingdom | 5 | 3 | 5 | 13 |
| Israel | 9 | 6 | 8 | 23 |
| France | 4 | 10 | 12 | 26 |
| Germany | 3 | 2 | 2 | 7 |
| Spain | 17 | 19 | 11 | 47 |
| Bulgaria | 3 | 1 | 2 | 6 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is terminated, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Elgan Pharma Ltd.