We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE January 20, 2021
First Posted Date  ICMJE February 1, 2021
Last Update Posted Date September 27, 2022
Actual Study Start Date  ICMJE October 28, 2021
Estimated Primary Completion Date March 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2021)
  • Number of incidence of AEs, TEAE, SAE as assessed by CTCAE v5.0 [ Time Frame: after multiple subcutaneous (SC) doses of 8 weeks ]
  • Number of incidence of clinical laboratory abnormalities [ Time Frame: after multiple subcutaneous (SC) doses of 8 weeks ]
  • Maximum Serum Concentration [Cmax] [ Time Frame: after multiple subcutaneous (SC) doses of 8 weeks ]
  • Time to reach Cmax [ Time Frame: after multiple subcutaneous (SC) doses of 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HM15136 Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI)
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Congenital Hyperinsulinism
Intervention  ICMJE Drug: HM15136
Low dose of HM15136/ High dose of HM15136, SC injection, weekly
Study Arms  ICMJE Experimental: HM15136 active
Cohort A / Cohort C
Intervention: Drug: HM15136
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 26, 2021)
16
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2025
Estimated Primary Completion Date March 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: JinHee Byeon +82 2 410 0485 jinhee.byeon@hanmi.co.kr
Listed Location Countries  ICMJE Germany,   Israel,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04732416
Other Study ID Numbers  ICMJE HM-GCG-201
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Hanmi Pharmaceutical Company Limited
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hanmi Pharmaceutical Company Limited
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hanmi Pharmaceutical Company Limited
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP