HM15136 (Efpegerglucagon) Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI)
Condition(s) studied
Investigational drug(s) / intervention(s)
HM15136: Low dose of HM15136/ High dose of HM15136, SC injection, weekly
Study 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.
Eligibility
Primary outcome measure(s)
- Number of incidence of AEs, TEAE, SAE as assessed by CTCAE v5.0 — after multiple subcutaneous (SC) doses of 8 weeks
- Number of incidence of clinical laboratory abnormalities — after multiple subcutaneous (SC) doses of 8 weeks
- Maximum Serum Concentration [Cmax] — after multiple subcutaneous (SC) doses of 8 weeks
- Time to reach Cmax — after multiple subcutaneous (SC) doses of 8 weeks
Trial sites (7)
| Facility | City | Region | Status |
|---|---|---|---|
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | |
| Otto-von-Guericke-Universitaet Magdeburg | Magdeburg | Germany | |
| Hadassah Medical Center (HMC) | Jerusalem | Israel | |
| Pusan National University Yangsan Hospital | Pusan | South Korea | |
| Asan Medical Center | Seoul | South Korea | |
| Great Ormond Street Hospital (GOSH) for Children NHS Foundation Trust | London | United Kingdom | |
| Central Manchester University Hospitals NHS Foundation Trust - Royal Manchester Children's Hospital - Centre for Paediatrics and Child Health | Manchester | United Kingdom |
More Hanmi Pharmaceutical Company Limited trials in South Korea
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04732416 on ClinicalTrials.gov ↗ ← All trials in South Korea