Assess the Safety of ELGN-2112 in Preterm Infants Born Under 26 Weeks GA &

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT05670951` - Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants	Phase 3
Completed	`NCT04791774` - Protein-bound Versus Free Amino Acid Nutrition During INtestinal Malabsorption in Critical Illness	N/A
Active, not recruiting	`NCT02510560` - Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants	Phase 3

See also

Status

Clinical Trial

Phase

Not yet recruiting

NCT05670951 - Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants

Phase 3

Completed

NCT04791774 - Protein-bound Versus Free Amino Acid Nutrition During INtestinal Malabsorption in Critical Illness

N/A

Active, not recruiting

NCT02510560 - Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants

Phase 3

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT05904626
Study type	Interventional
Source	Elgan Pharma Ltd.
Contact	Miki Olshansky
Phone	972-4-6098626
Email	CA@elganpharma.com
Status	Not yet recruiting
Phase	Phase 2
Start date	September 2023
Completion date	September 2025

Assess the Safety of ELGN-2112 in Preterm Infants Born Under 26 Weeks GA and IUGR Infants Born 26-32 Weeks GA

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms