12 completed, 1 active not recruiting, 1 recruiting, 1 terminated. 16 Phase 2, 3 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 16 | Completed 12, Active not recruiting 1, Recruiting 1, Terminated 1, Withdrawn 1 |
| Phase 1 | 3 | Completed 2, Terminated 1 |
| Phase 3 | 1 | Completed 1 |
Follow Congenital Hyperinsulinism: new trials by email Literature Review of Congenital Hyperinsulinism trials Research Report on Congenital Hyperinsulinism
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| HM15136 (Efpegerglucagon) Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI) HM15136 - Congenital Hyperinsulinism | Phase 2 | Active not recruiting | Hanmi Pharmaceutical Company Limited | 17 | 2022-05-05 | 2026-08-26 |
| Treatment of Post-bariatric Hypoglycaemia Dasiglucagon, HyoPen, Placebo - Hyperinsulinemic Hypoglycemia, Postprandial Hypoglycemia | Phase 2 | Completed | Filip Krag Knop | 24 | 2021-08-20 | 2023-02-02 |
| Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism dasiglucagon, Placebo - Congenital Hyperinsulinism | Phase 2 / Phase 3 | Completed | Zealand Pharma | 12 | 2020-06-19 | 2025-03-14 |
| An Open-Label Multiple Dose Study of RZ358 in Patients With Congenital Hyperinsulinism RZ358 Sequential Group Cohort 1, RZ358 Sequential Group Cohort 2, RZ358 Sequential Group Cohort 3 - Congenital Hyperinsulinism | Phase 2 | Completed | Rezolute | 23 | 2020-02-24 | 2025-05-28 |
| Dasiglucagon in the Treatment of Postprandial Hypoglycaemia After Roux-en-Y Gastric Bypass ZP4207, Placebo (saline) - Hyperinsulinemic Hypoglycemia, Postprandial Hypoglycemia | Phase 2 | Completed | University Hospital, Gentofte, Copenhagen | 10 | 2019-09-18 | 2020-03-31 |
| Glucagon Ready to Use (RTU) in Subjects With Hyperinsulinemic Hypoglycemia After Bariatric Surgery Glucagon RTU, Placebo - Hyperinsulinemic Hypoglycemia | Phase 2 | Completed | Xeris Pharmaceuticals | 14 | 2019-05-10 | 2020-05-21 |
| Pasireotide in Hyperinsulinemic Hypoglycemia Pasireotide 0.6Mg Solution for Injection, Saline Solution - Congenital Hyperinsulinism, Insulinoma | Phase 2 | Withdrawn | Montefiore Medical Center | 2017-04-01 | 2021-05-14 | |
| 18FluoroLDOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism 18F-Fluoro Dopa Imaging - Congenital Hyperinsulinism | Phase 2 | Recruiting | Miguel Pampaloni | 50 | 2016-11-03 | 2026-05-01 |
| CSI-Glucagon for Prevention of Hypoglycemia in Children With Congenital Hyperinsulinism Glucagon, Placebo - Congenital Hyperinsulinism | Phase 2 | Completed | Xeris Pharmaceuticals | 5 | 2016-10-01 | 2019-12-10 |
| A Single-Dose Open-Label Study of XOMA 358 in Subjects With Congenital Hyperinsulinism Cohort 1, Cohort 2, Cohort 3 - Congenital Hyperinsulinism | Phase 2 | Completed | XOMA (US) LLC | 10 | 2015-10-01 | 2017-02-06 |
| Effect of Exendin (9-39) on Glucose Requirements to Maintain Euglycemia Exendin (9-39), Vehicle - Congenital Hyperinsulinism | Phase 1 / Phase 2 | Terminated | Diva De Leon | 14 | 2009-08-26 | 2020-06-01 |
| Sandostatine® LP and Hyperinsulinism Sandostatine LP - Congenital Hyperinsulinism | Phase 2 | Completed | Assistance Publique - Hôpitaux de Paris | 10 | 2009-05-01 | 2013-12-19 |
| Effect of Exendin-(9-39) on Fasting Adaptation and Protein Sensitivity Exendin-(9-39), placebo - Congenital Hyperinsulinism | Phase 1 / Phase 2 | Completed | Diva De Leon | 17 | 2009-05-01 | 2020-03-13 |
| Phase II Safety and Efficacy Study of 18FDOPA PET-CT in Children With Hyperinsulinemic Hypoglycemia 18 F-DOPA - Congenital Hyperinsulinism (CHI), Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI) | Phase 2 | Completed | Children's Hospital of Philadelphia | 130 | 2009-01-01 | 2022-10-13 |
| Effect of Exendin-(9-39) on Glycemic Control in Subjects With Congenital Hyperinsulinism Exendin-(9-39), Vehicle - Congenital Hyperinsulinism | Phase 1 / Phase 2 | Completed | Diva De Leon | 9 | 2007-08-01 | 2017-12-11 |
| Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism F-DOPA, PET scan - Congenital Hyperinsulinism, Hyperinsulinism | Phase 2 | Completed | Children's Hospital of Philadelphia | 106 | 2004-12-01 | 2022-11-09 |
Hypoglycemia (9) · Hyperinsulinism (7) · Glucose Metabolism Disorders (2) · Metabolic Diseases (2) · Pancreatic Diseases (2) · Digestive System Diseases (1) · Infant, Newborn, Diseases (1) · Insulinoma (1)
Congenital, Hereditary, and Neonatal Diseases and Abnormalities (16) · Nutritional and Metabolic Diseases (16) · Digestive System Diseases (15) · Infant, Newborn, Diseases (15) · Glucose Metabolism Disorders (14) · Metabolic Diseases (14) · Pancreatic Diseases (14) · Hyperinsulinism (9) · Hypoglycemia (7) · Adenoma (1) · Adenoma, Islet Cell (1) · Digestive System Neoplasms (1) · Endocrine Gland Neoplasms (1) · Endocrine System Diseases (1) · Neoplasms (1)
dasiglucagon (3) · exendin (9-39) (3) · Glucagon (2) · Saline Solution (2) · fluorodopa F 18 (2) · HM15136 (1) · Injections (1) · KPNA1 protein, human (1) · Magnetic Resonance Spectroscopy (1) · Sodium Chloride (1) · Solutions (1) · pasireotide (1)
Diva De Leon (3) · Children's Hospital of Philadelphia (2) · Xeris Pharmaceuticals (2) · Assistance Publique - Hôpitaux de Paris (1) · Filip Krag Knop (1) · Hanmi Pharmaceutical Company Limited (1) · Miguel Pampaloni (1) · Montefiore Medical Center (1) · Rezolute (1) · University Hospital, Gentofte, Copenhagen (1) · XOMA (US) LLC (1) · Zealand Pharma (1)
United States (12) · United Kingdom (4) · Denmark (3) · Germany (3) · Israel (3) · Bulgaria (1) · Canada (1) · France (1) · Georgia (1) · Russia (1) · South Korea (1) · Spain (1) · Turkey (Türkiye) (1)
Lisa J States, MD (2) · Allan Gordon, MD, PhD (1) · Diva D De Leon, MD (1) · Diva D De Leon, MD MSCE (1) · Diva D DeLeon, MD (1) · Erika Brutsaert, M.D., M.P.H. (1) · Filip K Knop, MD, PhD (1) · Filip M. Knop, Prof., MD (1) · Jelena Ivkovic, MD (1) · Miguel Hernandez Pampaloni, MD, PhD (1) · Pascale De Lonlay, PUPH (1)
PMID 17236890, PMID 17895314, PMID 22855730, PMID 23414871, PMID 24314195, PMID 24314196, PMID 35320361, PMID 35416981, PMID 40107271
2017 (1), 2019 (1), R03DK078535 (1), R44DK105691 (1)