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To compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA and IUGR infants<3rd percentile* born at 26-32 weeks GA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ELGN-2112 Human insulin [rDNA] | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ELGN-2112 | Drug | To compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA and IUGR infants<3rd percentile* born at 26-32 weeks GA. |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA | Safety will be assessed by capturing of adverse events (AEs) during the treatment period. | Five days from birth until 42 days |
| Compare the safety of treatment with ELGN-2112 to placebo in preterm infants born IUGR infants<3rd percentile* born at 26-32 weeks GA. | Safety will be assessed by capturing of adverse events (AEs) during the treatment period. | Five days from birth until 42 days |
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Inclusion Criteria:
Exclusion Criteria:
N/A
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miki Olshansky | Contact | 972-4-6098626 | CA@elganpharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Miki Olshansky | Elgan Pharma Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laniado Hospital | Recruiting | Netanya | Israel |
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| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D008659 | Metabolic Diseases |
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| Placebo | Drug | A placebo formulation consisting of the same inactive ingredients as ELGN-2112. |
|
| D009750 | Nutritional and Metabolic Diseases |