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Clinical trials for Congenital hyperinsulinism

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    10 result(s) found for: Congenital hyperinsulinism. Displaying page 1 of 1.
    EudraCT Number: 2016-001275-80 Sponsor Protocol Number: X358605 Start Date*: 2016-08-25
    Sponsor Name:XOMA (US) LLC
    Full Title: An Open-Label Study of XOMA 358, with Optional Dose Escalation, in Patients with Congenital Hyperinsulinism
    Medical condition: Hypoglycemia associated with congenital hyperinsulinism
    Disease: Version SOC Term Classification Code Term Level
    19.0 10027433 - Metabolism and nutrition disorders 10077227 Hyperinsulinemic hypoglycemia LLT
    19.0 10027433 - Metabolism and nutrition disorders 10020644 Hyperinsulinism NOS LLT
    19.0 10027433 - Metabolism and nutrition disorders 10061211 Hyperinsulinism PT
    19.0 10027433 - Metabolism and nutrition disorders 10022484 Insulin hypoglycaemia LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2015-002692-18 Sponsor Protocol Number: 20150616 Start Date*: 2015-10-29
    Sponsor Name:European Commission
    Full Title: The physiology of glucagon-like peptide-1 receptor expression in patients with endogenous hyperinsulinism: correlation with histopathology
    Medical condition: Congenital hyperinsulinism
    Disease: Version SOC Term Classification Code Term Level
    18.0 10027433 - Metabolism and nutrition disorders 10061211 Hyperinsulinism PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Not Authorised)
    Trial results: (No results available)
    EudraCT Number: 2015-002847-32 Sponsor Protocol Number: X358602 Start Date*: 2015-11-02
    Sponsor Name:XOMA (US) LLC
    Full Title: A Single-Dose Open-Label Study of XOMA 358 in Subjects with Congenital Hyperinsulinism (HI)
    Medical condition: Hypoglycaemia associated with congenital hyperinsulinism
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004861 10020644 Hyperinsulinism NOS LLT
    19.0 100000004861 10022484 Insulin hypoglycaemia LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2016-004186-83 Sponsor Protocol Number: RZ358-606 Start Date*: 2017-04-11
    Sponsor Name:Rezolute, Inc.
    Full Title: An Open-Label Multiple-Dose Study of RZ358 in Patients with Congenital Hyperinsulinism
    Medical condition: Hypoglycemia associated with congenital hyperinsulinism
    Disease: Version SOC Term Classification Code Term Level
    20.1 10027433 - Metabolism and nutrition disorders 10077227 Hyperinsulinemic hypoglycemia LLT
    20.0 10027433 - Metabolism and nutrition disorders 10020644 Hyperinsulinism NOS LLT
    20.0 10027433 - Metabolism and nutrition disorders 10061211 Hyperinsulinism PT
    20.1 10027433 - Metabolism and nutrition disorders 10022484 Insulin hypoglycaemia LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) DK (Completed) BG (Completed) ES (Ongoing)
    Trial results: View results
    EudraCT Number: 2017-004547-21 Sponsor Protocol Number: ZP4207-17109 Start Date*: 2018-08-24
    Sponsor Name:Zealand Pharma A/S
    Full Title: A Two-Period, Open-label Trial Evaluating the Efficacy and Safety of Dasiglucagon for the Treatment of Children with Congenital Hyperinsulinism
    Medical condition: Children with congenital hyperinsulinism
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10061211 Hyperinsulinism PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed)
    Trial results: View results
    EudraCT Number: 2021-000508-39 Sponsor Protocol Number: HM-GCG-201 Start Date*: 2021-10-22
    Sponsor Name:Hanmi Pharm. Co., Ltd.
    Full Title: A Phase 2, Multiple Ascending Dose, Open-label, Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HM15136 Treatment for 8 Weeks in Subjects Aged ≥2 Year...
    Medical condition: Congenital Hyperinsulinism (CHI)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10061211 Hyperinsulinism PT
    23.0 100000004850 10083499 Congenital hyperinsulinemic hypoglycemia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-004546-15 Sponsor Protocol Number: ZP4207-17106 Start Date*: 2018-08-24
    Sponsor Name:Zealand Pharma A/S
    Full Title: An Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon for the Treatment of Children with Congenital Hyperinsulinism
    Medical condition: Children with congenital hyperinsulinism
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10061211 Hyperinsulinism PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-004545-24 Sponsor Protocol Number: ZP4207-17103 Start Date*: 2018-12-29
    Sponsor Name:Zealand Pharma A/S
    Full Title: A Randomized Trial in 2 Parts: Double-Blind, Placebo-Controlled, Crossover Part 1 and Open-label Part 2, Evaluating the Efficacy and Safety of Dasiglucagon for the Treatment of Children with Congen...
    Medical condition: Children with congenital hyperinsulinism
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10061211 Hyperinsulinism PT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2011-003633-33 Sponsor Protocol Number: MAXEPA01 Start Date*: 2011-09-29
    Sponsor Name:Central Manchester University Hospitals NHS Foundation Trust
    Full Title: The effect of purified fish oils on glucose regulation in Congenital Hyperinsulinism of Infancy (CHI)
    Medical condition: Congenital hyperinsulinism
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10062329 Congenital endocrine anomaly PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2014-003006-33 Sponsor Protocol Number: RUNMC-GLP1-EX-GELO-2014 Start Date*: 2015-02-16
    Sponsor Name:Radboud University Medical Center
    Full Title: Effect of Gelofusine on 111In-DTPA-AHX-Lys40-Exendin 4 uptake in the kidney
    Medical condition: The aim of this study is to reduce the kidney uptake during 111In-DTPA- exendin4 imaging, a promising and valuable tool for beta-cell mass imaging and quantification, which can be applied in patien...
    Disease: Version SOC Term Classification Code Term Level
    17.1 10014698 - Endocrine disorders 10018424 Glucose metabolism disorders (incl diabetes mellitus) HLGT
    17.1 10014698 - Endocrine disorders 10012602 Diabetes mellitus (incl subtypes) HLT
    17.1 10027433 - Metabolism and nutrition disorders 10012601 Diabetes mellitus PT
    17.1 10027433 - Metabolism and nutrition disorders 10067584 Type 1 diabetes mellitus PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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