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HM15136 Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04732416
Recruitment Status : Recruiting
First Posted : February 1, 2021
Last Update Posted : September 27, 2022
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

Brief Summary:
This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of HM15136 when used as add-on therapy in subjects with CHI with persistent hypoglycemia while on standard of care treatment (SoC). HM15136 will be administered once weekly in multiple doses to subjects in multiple age including pediatric to find appropriate exposure-response data.

Condition or disease Intervention/treatment Phase
Congenital Hyperinsulinism Drug: HM15136 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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 Years With Congenital Hyperinsulinism (CHI)
Actual Study Start Date : October 28, 2021
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HM15136 active
Cohort A / Cohort C
Drug: HM15136
Low dose of HM15136/ High dose of HM15136, SC injection, weekly




Primary Outcome Measures :
  1. Number of incidence of AEs, TEAE, SAE as assessed by CTCAE v5.0 [ Time Frame: after multiple subcutaneous (SC) doses of 8 weeks ]
  2. Number of incidence of clinical laboratory abnormalities [ Time Frame: after multiple subcutaneous (SC) doses of 8 weeks ]
  3. Maximum Serum Concentration [Cmax] [ Time Frame: after multiple subcutaneous (SC) doses of 8 weeks ]
  4. Time to reach Cmax [ Time Frame: after multiple subcutaneous (SC) doses of 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects aged ≥2 years with CHI with persistent hypoglycemia despite current SoC treatment according to the investigator's evaluation or documentation
  • Stable therapy with SoC medications with or without nutritional supplementation
  • Previously undergone near-total pancreatectomy or being treated with a nonsurgical approach, having been evaluated as not eligible for pancreatic surgery
  • HbA1c <7%

Exclusion Criteria:

  • Subjects with type 1 or type 2 diabetes mellitus
  • Other reasons for hypoglycemia, including but not limited to drug-induced hyperinsulinemic hypoglycemia, etc
  • Treatment of CHI with continuous intravenous glucose or glucagon infusion within 3 months prior to screening
  • Subjects with current use of any drugs that are known to interfere with the study drug, glucose metabolism, or study procedures (eg, use of systemic glucocorticoids [excluding topical, intra-articular or ophthalmic application, nasal spray, or inhaled forms] or insulin)
  • Have conditions that could affect glucose levels such as pheochromocytoma, insulinoma, and glucagonoma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04732416


Contacts
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Contact: JinHee Byeon +82 2 410 0485 jinhee.byeon@hanmi.co.kr

Locations
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United States, California
University of California Los Angeles Recruiting
Los Angeles, California, United States, 90095
Principal Investigator: Erin Okawa         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Kathleen Wharton       kseibel@wustl.edu   
Principal Investigator: Ana Maria Arbelaez         
United States, Pennsylvania
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Nicole Carter       carternd@chop.edu   
Principal Investigator: Diva De Leon-Crutchlow         
Germany
University Hospital Düsseldorf Not yet recruiting
Düsseldorf, Germany
Contact: Kummer         
Principal Investigator: Sebastian Kummer         
Otto-von-Guericke-Universitaet Magdeburg Recruiting
Magdeburg, Germany
Principal Investigator: Klaus Mohnike         
Israel
Hadassah Medical Center (HMC) Not yet recruiting
Jerusalem, Israel
Contact: Zangen         
Principal Investigator: David Zangen         
United Kingdom
Great Ormond Street Hospital (GOSH) for Children NHS Foundation Trust Recruiting
London, United Kingdom
Principal Investigator: Antonia Dastamani         
Central Manchester University Hospitals NHS Foundation Trust - Royal Manchester Children's Hospital - Centre for Paediatrics and Child Health Not yet recruiting
Manchester, United Kingdom
Principal Investigator: Indi Banerjee         
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
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Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT04732416    
Other Study ID Numbers: HM-GCG-201
First Posted: February 1, 2021    Key Record Dates
Last Update Posted: September 27, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Congenital Hyperinsulinism
Nesidioblastosis
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pancreatic Diseases
Digestive System Diseases
Infant, Newborn, Diseases
Hypoglycemia