Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants
Recruiting
Phase 3
Interventional Study
Intestinal Malabsorption
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 1 Day – 5 Days
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 360 (estimated)
- Sponsor
- Elgan Pharma Ltd. · Industry
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About This Trial
The study will evaluate the effect of ELGN-2112 on intestinal malabsorption in preterm infants.
Trial Locations
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Eligibility Criteria
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:
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Contacts
No contact information available.