Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-02-20 @ 1:34 PM
Study NCT ID:
NCT02510560
Status:
TERMINATED
Last Update Posted:
2025-08-19
First Post:
2015-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants
Sponsor:
Elgan Pharma Ltd.
Organization:
Study Overview
Official Title:
A Multi-center, Double-blind, Randomized, Three-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants
Status:
TERMINATED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will evaluate the effect of NTRA-2112 on intestinal malabsorption in preterm infants.
Detailed Description:
The study will assess the efficacy and safety of NTRA-2112 on intestinal malabsorption in preterm infants as compared to placebo
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: