Clinical trial • Phase III • Other
INSULIN HUMAN for Intestinal malabsorption
Phase III trial of INSULIN HUMAN for Intestinal malabsorption.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Intestinal malabsorption
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
- Paediatric Trial
- Yes
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 02-10-2024
- First CTIS Authorization Date
- 25-10-2024
Trial design
Randomised, elgn-2112 (insulin human) oral solution administered via enteral feeding tube; dosing unit reported as iu/kg with max daily dose 0.3 iu/kg and maximum treatment period 28 days. comparator (placebo): powder for reconstitution for enteral administration (placebo), no active substance listed.-controlled Phase III trial across 25 sites in France, Netherlands, Spain and others.
- Randomised
- Yes
- Comparator
- ELGN-2112 (INSULIN HUMAN) oral solution administered via enteral feeding tube; dosing unit reported as IU/kg with max daily dose 0.3 IU/kg and maximum treatment period 28 days. Comparator (placebo): Powder for reconstitution for enteral administration (placebo), no active substance listed.
- Target Sample Size
- 295
- Trial Duration For Participant
- 730
Eligibility
Recruits 295 paediatric patients.
- Vulnerable Population
- Trial population: preterm infants (neonates), identified as a vulnerable population. Informed consent must be provided by parent(s) or legal guardian; the documentation specifies that one of the two parents/legal guardians or both may provide consent according to local regulations. No participant assent is applicable given the neonatal population.
Inclusion criteria
- {"criterion_text":"- Male or female preterm infants born at a gestational age 26+0 to 31+6 weeks. Gestational age matching (±2 weeks) between maternal dates and/or early antenatal ultrasound\n- Infant is expected to wean off parenteral nutrition (PN) at the primary hospital\n- Informed consent form signed by parent(s) or legal guardian\n- In the Investigator’s opinion, the infant is sufficiently stable to partake in the trial to completion\n- (France only) - only participants benefiting from a health insurance plan can participate in research\n- Birth weight ≥ 500 g\n- Singleton or twin birth\n- Postnatal age up through and including Day 5 (up to 120 hours post birth)\n- Fraction of inspired oxygen ≤ 0.60 at enrolment\n- Infant is cardiovascularly stable at time of enrolment and would be considered unstable if they require inotropic support\n- Infant is able to tolerate enteral feeds (defined as minimum of 10 ml/kg/day)"}
Exclusion criteria
- {"criterion_text":"- Infant is consuming more than 80 ml/kg/day enterally at study entry\n- Maternal diabetes (Type I/II or gestational) requiring insulin during pregnancy or in mothers past medical history\n- Confirmed hyperinsulinemia or suspected hyperinsulinemia requiring glucose administration of more than 12 mg/kg/min at randomization\n- Any systemic insulin administration at randomization\n- Nothing per os (NPO) at study entry and enteral/oral supplements are not allowed\n- Hypersensitivity to any of the drug components- Recombinant Human Insulin (rh-Insulin), Maltodextrin, Sodium Chloride\n- Infant is receiving pharmacological treatment for a hemodynamically significant PDA at the time of randomization\n- Heart and chest compression or any resuscitation drugs given to the infant during delivery\n- Subjects at risk for significant GI complications such as twin-to-twin transfusion syndrome (TTTS) or monochorionic monoamniotic twins\n- Participation in another interventional clinical study that may interfere with the results of this trial\n- Infant is not dependent on any parenteral amino acids/lipids as nutrition\n- Major congenital malformation (e.g., infants with genetic, metabolic, and/or endocrine disorder diagnosed before enrolment)\n- Intra-uterine growth restriction (IUGR) defined as weight for gestational age less than the third percentile according to Fenton preterm growth chart\n- Confirmed NEC"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Number of days from treatment initiation to achieve full enteral feeding*, which is defined as the number of days to achieve enteral feeding of at least 150 ml/kg/day for three consecutive days during the treatment period *Defined as first day of reaching three consecutive days of EN feeds ≥150 ml/kg/day","definition_or_measurement_approach":"Defined as first day of reaching three consecutive days of enteral (EN) feeds ≥150 ml/kg/day; measured as number of days from treatment initiation to that first day."}
Secondary endpoints
- {"endpoint_text":"- The number of days from treatment initiation to PN wean-off during the treatment period","definition_or_measurement_approach":""}
- {"endpoint_text":"- Incidence of severe NEC (modified Bell’s stage ≥2a) by 40 weeks post-menstrual age (PMA) or discharge home, whichever is earlier, in infants born at 26+0-28+6 weeks GA (FIT-PIV study) and infants born less than 26+0 weeks GA and IUGR infants born at 26+0-31+6 weeks GA (FIT-05 study) as assessed by central blinded reviewers and classified according to the “Modified Bell’s Staging Criteria for NEC” (Walsh-1986).","definition_or_measurement_approach":"Assessed by central blinded reviewers and classified according to the Modified Bell’s Staging Criteria for NEC (Walsh-1986); timepoint: by 40 weeks PMA or discharge home, whichever is earlier."}
- {"endpoint_text":"- Incidence of severe NEC (modified Bell’s stage ≥2a) by 40 weeks PMA or discharge home, whichever is earlier, in infants born at 26+0-28+6 weeks GA as assessed by central blinded reviewers and classified according to the “Modified Bell’s Staging Criteria for NEC” (Walsh-1986).","definition_or_measurement_approach":"Assessed by central blinded reviewers and classified according to the Modified Bell’s Staging Criteria for NEC (Walsh-1986); timepoint: by 40 weeks PMA or discharge home."}
- {"endpoint_text":"- The number of days from treatment initiation to discharge from primary hospital","definition_or_measurement_approach":""}
- {"endpoint_text":"- Distribution of severity of NEC by 40 weeks PMA or discharge home, whichever is earlier, in infants born at 26+0-28+6 weeks GA (FIT-PIV study) and infants born less than 26+0 weeks GA and IUGR infants born at 26+0-31+6 weeks GA (FIT-05 study) as assessed by central blinded reviewers and classified according to the “Modified Bell’s Staging Criteria for NEC” (Walsh-1986) - pooled analysis","definition_or_measurement_approach":"Pooled analysis; classification per Modified Bell’s Staging Criteria for NEC (Walsh-1986); timepoint by 40 weeks PMA or discharge home."}
- {"endpoint_text":"- Distribution of severity of NEC by 40 weeks PMA or discharge home, whichever is earlier, according to modified Bell’s staging in infants born at 26+0-28+6 weeks GA as assessed by central blinded reviewers and classified according to the “Modified Bell’s Staging Criteria for NEC” (Walsh-1986).","definition_or_measurement_approach":"Classified per Modified Bell’s Staging Criteria for NEC (Walsh-1986); timepoint by 40 weeks PMA or discharge home."}
- {"endpoint_text":"- Incidence of severe NEC by 40 weeks PMA or discharge home, whichever is earlier, in the entire study population as assessed by central blinded reviewers and classified according to the “Modified Bell’s Staging Criteria for NEC” (Walsh-1986).","definition_or_measurement_approach":"Assessed by central blinded reviewers and classified per Modified Bell’s Staging Criteria for NEC (Walsh-1986); timepoint by 40 weeks PMA or discharge home."}
- {"endpoint_text":"- Distribution of severity of NEC by 40 weeks PMA or discharge home, whichever is earlier, in the entire study population as assessed by central blinded reviewers and classified according to the “Modified Bell’s Staging Criteria for NEC” (Walsh-1986).","definition_or_measurement_approach":"Classified per Modified Bell’s Staging Criteria for NEC (Walsh-1986); timepoint by 40 weeks PMA or discharge home."}
- {"endpoint_text":"- Percentage of infants reaching FEF for three consecutive days within 6, 8, and 10 days from treatment initiation","definition_or_measurement_approach":"FEF defined as enteral feeding ≥150 ml/kg/day for three consecutive days; measured within specified time windows (6, 8, 10 days from treatment start)."}
- {"endpoint_text":"- The number of days from treatment initiation to the first day the infant achieves EN volume of 120 ml/kg/day for three consecutive days during the treatment period","definition_or_measurement_approach":"Measured as number of days from treatment start to first day of three consecutive days with EN volume ≥120 ml/kg/day."}
- {"endpoint_text":"- Percentage of infants weaned off PN within 4, 6, and 8 days from treatment initiation","definition_or_measurement_approach":""}
- {"endpoint_text":"- Neonatal anthropometrics measurements during the treatment period and up to 3 months CA.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Percentage of EN and PN over total nutrition during the treatment period","definition_or_measurement_approach":""}
- {"endpoint_text":"- Incidence of late onset sepsis (onset ≥72 hours after birth) by 40 weeks PMA or discharge home, whichever is earlier. Will be defined as either: a) culture proven late onset sepsis, OR b) clinically suspected culture negative late onset sepsis","definition_or_measurement_approach":"Defined as either culture-proven late-onset sepsis or clinically suspected culture-negative late-onset sepsis (onset ≥72 hours after birth); timepoint by 40 weeks PMA or discharge home."}
- {"endpoint_text":"- Incidence of at least one of the adverse events of relevance by 40 weeks PMA or discharge home, whichever is earlier: • severe NEC (modified Bell’s stage ≥2a); • late-onset sepsis • death.","definition_or_measurement_approach":""}
- {"endpoint_text":"- The number of days from treatment initiation to discharge to home","definition_or_measurement_approach":""}
- {"endpoint_text":"- Incidence and severity of ROP up to 3 months CA according to the International Classification of Retinopathy of Prematurity (ICROP3)","definition_or_measurement_approach":"Assessed up to 3 months corrected age according to ICROP3."}
- {"endpoint_text":"- Adverse Events (AEs) and Adverse Drug Reaction (ADRs); Blood glucose; Blood chemistry and haematology; Vital signs","definition_or_measurement_approach":""}
- {"endpoint_text":"- Major morbidities (including cerebral palsy, severe vision and hearing loss and hospitalisation) at 6, 12 and 24 months CA; Anthropometrics measurements at 6, 12 and 24 months CA; Neurodevelopmental assessment at 24 months CA","definition_or_measurement_approach":"Long-term follow-up assessments at specified corrected ages (6, 12, 24 months); neurodevelopmental assessment at 24 months CA."}
Recruitment
- Planned Sample Size
- 295
- Recruitment Window Months
- 95
- Consent Approach
- Informed consent must be signed by parent(s) or legal guardian. The documentation states that one of the two parents/legal guardians or both may provide consent in accordance with local regulations. Parental/legal guardian consent is required; assent is not applicable for the neonatal population.
Geography
- Total Number Of Sites
- 25
- Total Number Of Participants
- 295
France
- Earliest CTIS Part Ii Submission Date
- 17-10-2024
- Latest Decision Or Authorization Date
- 28-10-2024
- Processing Time Days
- 11
- Number Of Sites
- 4
- Number Of Participants
- 30
Sites
- Site Name
- Centre Hospitalier Universitaire De Nimes
- Department Name
- Neonatology
- Contact Person Name
- Massimo DI MAIO
- Contact Person Email
- massimo.dimaio@chu-nimes.fr
- Site Name
- Centre Hospitalier Intercommunal De Poissy Saint Germain
- Department Name
- Neonatology
- Contact Person Name
- Emmanuelle MOTTE SIGNORET
- Contact Person Email
- emmanuelle.mottesignoret@ght-yvelinesnord.fr
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Neonatology
- Contact Person Name
- Alain BEUCHEE
- Contact Person Email
- alain.beuchee@chu-rennes.fr
- Site Name
- Hopital Necker Enfants Malades
- Department Name
- Neonatology
- Contact Person Name
- Alexandre LAPILLONNE
- Contact Person Email
- alexandre.lapillonne@aphp.fr
Netherlands
- Earliest CTIS Part Ii Submission Date
- 17-10-2024
- Latest Decision Or Authorization Date
- 25-10-2024
- Processing Time Days
- 8
- Number Of Sites
- 3
- Number Of Participants
- 70
Sites
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Neonatology
- Contact Person Name
- Elisabeth Kooi
- Contact Person Email
- e.kooi@umcg.nl
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Neonatology
- Contact Person Name
- Chris van den Akker
- Contact Person Email
- c.h.vandenakker@amsterdamumc.nl
- Site Name
- Isala Klinieken Stichting
- Department Name
- Neonatology
- Contact Person Name
- Marieke Hemels
- Contact Person Email
- m.a.c.hemels@isala.nl
Spain
- Earliest CTIS Part Ii Submission Date
- 17-10-2024
- Latest Decision Or Authorization Date
- 28-10-2024
- Processing Time Days
- 11
- Number Of Sites
- 6
- Number Of Participants
- 60
Sites
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Pediatric
- Contact Person Name
- Isabel Izquierdo
- Contact Person Email
- m.isabel.izquierdo@uv.es
- Site Name
- Hospital Universitario La Paz
- Department Name
- Pediatric
- Contact Person Name
- Miguel Saenz de Pipaon
- Contact Person Email
- miguel.saenz@salud.madrid.org
- Site Name
- Complejo Hospitalario Universitario Insular Materno Infantil
- Department Name
- Pediatric
- Contact Person Name
- Fermín García-Muñoz
- Contact Person Email
- fgarciamu@gmail.com
- Site Name
- Hospital Clinico Universitario Lozano Blesa
- Department Name
- Pediatric
- Contact Person Name
- Gerardo Rodríguez Martinez
- Contact Person Email
- gerard@unizar.es
- Site Name
- University Hospital Son Espases
- Department Name
- Pediatric
- Contact Person Name
- Marta Bernardino Collado
- Contact Person Email
- marta.bernardino@ssib.es
- Site Name
- Hospital Universitario Miguel Servet
- Department Name
- Pediatric
- Contact Person Name
- Segundo Rite Gracia
- Contact Person Email
- segundorite@gmail.com
Austria
- Earliest CTIS Part Ii Submission Date
- 17-10-2024
- Latest Decision Or Authorization Date
- 30-10-2024
- Processing Time Days
- 13
- Number Of Sites
- 1
- Number Of Participants
- 25
Sites
- Site Name
- University Hospital Salzburg
- Department Name
- UK für Kinder- und Jugendheilkunde der PMU Salzburg - Division für Neonatalogie
- Contact Person Name
- Edda Hofstätter
- Contact Person Email
- e.hofstaetter@salk.at
Sweden
- Earliest CTIS Part Ii Submission Date
- 17-10-2024
- Latest Decision Or Authorization Date
- 28-10-2024
- Processing Time Days
- 11
- Number Of Sites
- 5
- Number Of Participants
- 50
Sites
- Site Name
- Norrlands Universitetssjukhus
- Department Name
- Department of Pediatrics
- Contact Person Name
- Magnus Domellöf
- Contact Person Email
- magnus.domellof@umu.se
- Site Name
- Skanes University Hospital
- Department Name
- Department of Pediatrics
- Contact Person Name
- Ingrid Hansen Pupp
- Contact Person Email
- karl.dreja@skane.se
- Site Name
- Skane University Hospital, Malmo
- Department Name
- Department of Pediatrics
- Contact Person Name
- Ingrid Hansen Pupp
- Contact Person Email
- ingrid.pupp@med.lu.se
- Site Name
- Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen
- Department Name
- Department of Women's and Children's Health
- Contact Person Name
- Anders Elfvin
- Contact Person Email
- anders.elfvin@vgregion.se
- Site Name
- Uppsala University Hospital
- Department Name
- Department of Pediatrics
- Contact Person Name
- Fredrik Ahlsson
- Contact Person Email
- fredrik.ahlsson@uu.se
Italy
- Earliest CTIS Part Ii Submission Date
- 02-07-2025
- Latest Decision Or Authorization Date
- 25-09-2025
- Processing Time Days
- 85
- Number Of Sites
- 6
- Number Of Participants
- 60
Sites
- Site Name
- Azienda Ospedaliera di Padova
- Department Name
- Dipartimento di Salute della Donna e del Bambino
- Contact Person Name
- Giovanna Verlato
- Contact Person Email
- giovanna.verlato@aopd.veneto.it
- Site Name
- Policlinico Casilino
- Department Name
- UO Neonatologia, Patologia Neonatale e Terapia Intensiva Neonatale
- Contact Person Name
- Simonetta Costa
- Contact Person Email
- scosta.polcas@eurosanita.it
- Site Name
- Azienda Ospedaliero Universitaria Delle Marche
- Department Name
- SOD Neonatologia
- Contact Person Name
- Maria Paola Bellagamba
- Contact Person Email
- mariapaola.bellagamba@ospedaliriuniti.marche.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- U.O.C. Neonatologia
- Contact Person Name
- Giovanni Vento
- Contact Person Email
- giovanni.vento@policlinicogemelli.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- Unità Operativa di Neonatologia e Terapia Intensiva Neonatale
- Contact Person Name
- Orsola Amato
- Contact Person Email
- orsola.amato@policlinico.mi.it
- Site Name
- San Camillo Forlanini Hospital
- Department Name
- UOC Neonatologia e Terapia Intensiva Neonatale
- Contact Person Name
- Luca Maggio
- Contact Person Email
- LMaggio@scamilloforlanini.rm.it
Sponsor
Primary sponsor
- Full Name
- Elgan Pharma Ltd.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Israel
Contract research organisations
- Name
- Bioclinica Inc.
- Responsibilities
- Central imaging systems
- Name
- Icon Clinical Research Limited
- Responsibilities
- sponsorDuties codes: 10, 6
- Name
- Premier Research Group Limited
- Responsibilities
- sponsorDuties codes: 1,10,11,12,2,3,5,6,7,8
- Name
- Medidata Solutions Inc.
- Responsibilities
- sponsorDuties codes: 7
Third parties
- {"country":"Germany","full_name":"PCI Pharma Services Germany GmbH","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central imaging systems","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient travel reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Israel","full_name":"Bioforum C.D.M.C Ltd.","duties_or_roles":"Unblinded Statistics for DMC meetings","organisation_type":"Pharmaceutical company"}
- {"country":"Italy","full_name":"Lb Research S.r.l.","duties_or_roles":"sponsorDuties codes: 1","organisation_type":"Pharmaceutical company"}
- {"country":"Spain","full_name":"Servicio De Asesoria A La Investigacion Y Logistica S.L.","duties_or_roles":"sponsorDuties codes: 1","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: 10, 6","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Premier Research Group Limited","duties_or_roles":"sponsorDuties codes: 1,10,11,12,2,3,5,6,7,8","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- ELGN-2112
- Active Substance
- INSULIN HUMAN
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- ENTERAL FEEDING TUBE
- Route
- Enteral feeding tube
- Orphan Designation
- Yes
- Maximum Dose
- 0.3 IU/kg (max daily dose)
- Investigational Product Name
- Powder for reconstitution for enteral administration
- Modality
- Other
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