Clinical trials: Neonatal Hypoglycemia
Congenital Hyperinsulinism
Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in Children With Congenital Hyperinsulinism
This is an open-label, multinational, multicenter, long-term safety and efficacy extension trial in patients with Congenital Hyperinsulinism (CHI) who completed either ZP4207-17103 (NCT04172441) or ZP4207-17109 (NCT03777176)…
- Trial name
- NCT03941236
- Testing
- dasiglucagon
- Where
- 10 sites in United States, Germany and 2 more
- Volunteers
- 42 people
- Sponsor
- Zealand Pharma
Congenital Hyperinsulinism
A Two-Period Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
The objective of the trial is to evaluate the efficacy and safety of dasiglucagon administered as a subcutaneous (SC) infusion in reducing hypoglycemia in children with CHI.
- Trial name
- NCT03777176
- Testing
- Dasiglucagon, Standard of Care
- Where
- 10 sites in United States, Germany and 2 more
- Volunteers
- 32 people
- Sponsor
- Zealand Pharma
Congenital Hyperinsulinism
Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
The objective of the trial is to evaluate the efficacy of dasiglucagon in reducing glucose requirements in children with persistent congenital hyperinsulinism (CHI) requiring continuous intravenous (IV) glucose administration to…
- Trial name
- NCT04172441
- Testing
- dasiglucagon
- Where
- 6 sites in United States, Germany and 2 more
- Volunteers
- 12 people
- Sponsor
- Zealand Pharma
Glycogen Storage Disease Type III
Clinical Survey Study to Assess Physical Function and the Incidence of Hypoglycemia in Participants With Glycogen Storage Disease Type III
The primary objective of this study is to evaluate the incidence of hypoglycemia in adult and pediatric participants with glycogen storage disease type III (GSD III).
- Trial name
- NCT05196165
- Testing
- No Intervention
- Where
- 4 sites in United States, Netherlands
- Volunteers
- 14 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Congenital Hyperinsulinism
HM15136 (Efpegerglucagon) Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI)
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).
- Trial name
- NCT04732416
- Testing
- HM15136
- Where
- 7 sites in United States, Germany and 3 more
- Volunteers
- 17 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Hyperinsulinemic Hypoglycemia
Glucagon Ready to Use (RTU) in Subjects With Hyperinsulinemic Hypoglycemia After Bariatric Surgery
This is a double-blind, placebo-controlled Phase 2 study to assess the efficacy, safety and tolerability of Glucagon RTU when administered to subjects with a history of bariatric surgery during episodes of post-postprandial…
- Trial name
- NCT03770637
- Testing
- Glucagon RTU
- Where
- 5 sites in United States
- Volunteers
- 14 people
- Sponsor
- Xeris Pharmaceuticals
Congenital Hyperinsulinism
A Single-Dose Open-Label Study of XOMA 358 in Subjects With Congenital Hyperinsulinism
The purpose of this study is to evaluate the safety and clinical pharmacology of a single dose pharmacokinetics and pharmacodynamics of XOMA 358 in subjects with hypoglycemia associated with congenital hyperinsulinism.
- Trial name
- NCT02604485
- Testing
- Cohort 1, Cohort 2, Cohort 3
- Where
- 2 sites in United States, United Kingdom
- Volunteers
- 10 people
- Sponsor
- XOMA (US) LLC
Congenital Hyperinsulinism
CSI-Glucagon for Prevention of Hypoglycemia in Children With Congenital Hyperinsulinism
This is a Phase 2, multi-center, randomized, placebo-controlled, double-blind trial with open-label follow-up designed to assess the efficacy of Xeris Glucagon delivered as a continuous subcutaneous infusion to prevent…
- Trial name
- NCT02937558
- Testing
- Glucagon
- Where
- 5 sites in United States
- Volunteers
- 5 people
- Sponsor
- Xeris Pharmaceuticals