12 completed. 12 Phase 2, 2 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 12 | Completed 12 |
| Phase 1 | 2 | Completed 2 |
| 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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 (8) · Hyperinsulinism (5) · Digestive System Diseases (1) · Glucose Metabolism Disorders (1) · Metabolic Diseases (1) · Pancreatic Diseases (1)
Congenital, Hereditary, and Neonatal Diseases and Abnormalities (12) · Infant, Newborn, Diseases (12) · Nutritional and Metabolic Diseases (12) · Digestive System Diseases (11) · Glucose Metabolism Disorders (11) · Metabolic Diseases (11) · Pancreatic Diseases (11) · Hyperinsulinism (7) · Hypoglycemia (4)
dasiglucagon (3) · Glucagon (2) · exendin (9-39) (2) · fluorodopa F 18 (2) · KPNA1 protein, human (1) · Magnetic Resonance Spectroscopy (1) · Saline Solution (1) · Sodium Chloride (1)
Children's Hospital of Philadelphia (2) · Diva De Leon (2) · Xeris Pharmaceuticals (2) · Assistance Publique - Hôpitaux de Paris (1) · Filip Krag Knop (1) · Rezolute (1) · University Hospital, Gentofte, Copenhagen (1) · XOMA (US) LLC (1) · Zealand Pharma (1)
United States (9) · Denmark (3) · United Kingdom (3) · Germany (2) · Israel (2) · Bulgaria (1) · Canada (1) · France (1) · Georgia (1) · Russia (1) · Spain (1) · Turkey (Türkiye) (1)
Lisa J States, MD (2) · Allan Gordon, MD, PhD (1) · Diva D De Leon, MD (1) · Diva D DeLeon, MD (1) · Filip K Knop, MD, PhD (1) · Filip M. Knop, Prof., MD (1) · Jelena Ivkovic, MD (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)