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
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Study to Evaluate the Efficacy and Safety of RZ358 in Patients With Congenital Hyperinsulinism. For more information on this trial, visit: Citeline Connect: sunRIZE RZ358
Or contact Rezolute at [email protected].

Current Clinical Research to Better Understand Congenital HI

Children’s Hospital of Philadelphia, Research Institute
“Neurocognition in Hyperinsulinism:” Research Study on how cognitive function changes over time in children with hyperinsulinism (HI) compared to children who are healthy volunteers. For more information on this trial, visit: https://www.research.chop.edu/neurocognition-in-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