Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT05670951
Status:
RECRUITING
Last Update Posted:
2025-05-28
First Post:
2023-01-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008286', 'term': 'Malabsorption Syndromes'}], 'ancestors': [{'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2029-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2023-01-02', 'studyFirstSubmitQcDate': '2023-01-02', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numbers of days to achieve full enteral feeding', 'timeFrame': '28 days or discharge from hospital'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intestinal Malabsorption']}, 'descriptionModule': {'briefSummary': 'The study will evaluate the effect of ELGN-2112 on intestinal malabsorption in preterm infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Days', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* Birth weight ≥ 500g\n* Singleton or twin birth\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05670951', 'briefTitle': 'Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Elgan Pharma Ltd.'}, 'officialTitle': 'A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants', 'orgStudyIdInfo': {'id': 'FIT-PIV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ELGN-2112', 'interventionNames': ['Drug: ELGN-2112']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ELGN-2112', 'type': 'DRUG', 'description': 'Human insulin \\[rDNA\\]', 'armGroupLabels': ['ELGN-2112']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4244916', 'city': 'Netanya', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Tilly Bernat', 'role': 'CONTACT', 'email': 'tbernat@laniado.org.il', 'phone': '972-8609118'}, {'name': 'Arya Simonds, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Laniado Hospital', 'geoPoint': {'lat': 32.33291, 'lon': 34.85992}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elgan Pharma Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}