Long Term Follow Up Safety Assessment After Treatment with ELGN-2112 For Intestinal Malabsorption in Preterm Infants

Long Term Follow Up Safety Assessment After Treatment with ELGN-2112 For Intestinal Malabsorption in Preterm Infants - Long Term Follow Up Safety Assessment After Treatment with ELGN-2112 For Intestinal Malabsorption in Preterm Infants

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON61194

Enrollment

Registered

2025-02-05

Start date

2026-02-01

Completion date

Unknown

Last updated

2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intestinal malabsorption disturbed absorption of nutrients

Interventions

not applicable&nbsp

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: 1.    Participated in the FIT-04 study and received at least one study drug dose. 2.    Informed consent form to participate in the follow up study signed by parent/s or legal guardian   

Exclusion criteria

Exclusion criteria: Families who withdrew their consent in FIT-04 study would not be invited or contacted for this study.

Design outcomes

Primary

Measure	Time frame
To assess long-term safety after treatment with ELGN-2112 compared to placebo for intestinal malabsorption in preterm infants	—

Secondary

Measure	Time frame
To describe developmental outcomes up to 6-10 years of age in children treatment with ELGN-2112 or placebo	—

Countries

France, Israel, Italy, Netherlands, Spain, United Kingdom

Contacts

Public ContactB Ohayon

ELGAN Pharma Ltd.

batel@elganpharma.com+972 547433526

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 11, 2026