Importance of Clinical Research
One of CHI’s important roles is to inform the patient community of clinical research opportunities in order to help raise awareness of and increase participation in clinical research and clinical trials; research is necessary to accelerate the development of new drugs and treatments for patients. CHI’s role does not include endorsing specific studies. CHI strongly recommends discussing clinical research participation for each specific study with your physician specialist or healthcare provider.
A clinical research trial is a research project conducted with human volunteers to learn more about new investigational drugs. Every new therapy or device must go through carefully monitored studies in human volunteers before it is commercially available.
The HI community needs new therapies and approaches for patients who do not respond to currently available treatments, and clinical trials that safeguard the health of study participants are necessary for the development of new HI products. Clinicaltrials.gov’s webpage provides a listing of studies for Congenital Hyperinsulinism. If you find a clinical trial of interest to you, be sure to click on that specific trial to see all the clinical trial sites. You can also click on this map to see congenital hyperinsulinism clinical trials by geographic area.
The U.S. National Institute of Health (NIH) has a very good website on clinical trial participation. Please visit: www.nih.gov/health-information/nih-clinical-research-trials-you
You can learn more about the clinical research process and the importance of patient participation from this presentation from the 2020 CHI Collaborative Research Network Virtual Convening.
Clinical Trial Information
ClinicalTrials.gov’s webpage provides a listing of studies for Congenital Hyperinsulinism. If you find a clinical trial of interest to you, be sure to click on that specific trial to see all the clinical trial sites. You can also click on this map to see congenital hyperinsulinism clinical trials by geographic area around the world.
Other International Clinical Trial Information:
EU Clinical Trials Register
https://www.clinicaltrialsregister.eu/ctr-search/search
Australia New Zealand Clinical Trials Registry
https://www.anzctr.org.au/Default.aspx
WHO International Clinical Trials Registry
https://www.who.int/clinical-trials-registry-platform/the-ictrp-search-portal
Current Clinical Research Trials for New Congenital HI Treatments
Hanmi
HM15136 Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI)
For more information on this trial visit: https://achieve.study/
Rezolute
An Open-Label Multiple Dose Study of RZ358 in Patients with Congenital Hyperinsulinism (RIZE Trial)
For more information on this trial, visit: https://connect.trialscope.com/studies/5837c52d-e200-4a2a-83c5-562ae1513225?pv=1
Or contact Rezolute at clinicaltrials@rezolutebio.com.
Zealand
Trial Evaluating Efficacy and Safety of Dasiglucagon in Children with Congenital Hyperinsulinism.
For more information contact Zealand at cts@zealandpharma.com.
ClinicalTrials.gov Identifier: NCT04172441
Current Clinical Research to Better Understand Congenital HI
Children’s Hospital of Philadelphia
“Blood Sugar Stability in Individuals with Hyperinsulinism.” The purpose of this study is to evaluate blood sugar levels and beta-cell function in adolescents and adult with KATP hyperinsulinism whom did not undergo pancreatectomy. For more information, visit: https://www.research.chop.edu/blood-sugar-stability-in-individuals-with-hyperinsulinism
Children’s Hospital of Philadelphia
Research Study for Individuals with Hyperinsulinism, Type 1 Diabetes Mellitus, and Healthy Children.
For more information on this trial, visit: https://www.research.chop.edu/research-study-for-individuals-with-hyperinsulinism-type-1-diabetes-mellitus-and-healthy-children
Children’s Hospital of Philadelphia
Expanded Access Use of 18F-L-Fluoro-DOPA PET/CT Scan Localization of Focal Pancreatic Lesions in Subjects With Hyperinsulinemic Hypoglycemia
For more information on this trial, visit: https://www.chop.edu/pages/18f-dopa-petct-scan-prior-surgery-hyperinsulinism
