CHART study
Research type
Research Study
Full title
Congenital Hyperinsulinism: A Retrospective Longitudinal Study (CHART)
IRAS ID
302152
Contact name
Eva Bøge
Contact email
Sponsor organisation
Zealand Pharma A/S
Clinicaltrials.gov Identifier
302152, IRAS ID
Duration of Study in the UK
0 years, 5 months, 31 days
Research summary
This study is a multinational retrospective (in the past), medical records review of 200 congenital hyperinsulinism (CHI) patients (cases) between birth and 12 years of age.
This study will be conducted at 6 study centres located in the United States (2), United Kingdom, France, and Germany (2).
The purpose of this study is to better understand and describe congenital hyperinsulinism (CHI) disease characteristics, diagnosis, burden of illness, resource utilization, treatment, and outcomes over a historical period of up to 5 years. A key objective for CHART study is to provide important perspectives on the natural history of key subsets of CHI as reflected in actual medical practice settings. Data obtained from the CHART study will be used to fill important information gaps on treatments and outcomes in real-world settings, which may differ notably from those described in current published literature. In addition, the CHART dataset can serve as an external, real-world historical comparator against which data from the dasiglucagon clinical trial program can be contrasted and may be used to identify factors predictive of specific CHI outcomes.
There are no procedures, clinic visits, or medications that will be used in this study, only a review of medical records will be required. It is expected that the study doctor and or the study team will review patient’s medical records for a period of about 5 months.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
21/PR/1077
Date of REC Opinion
25 Aug 2021
REC opinion
Further Information Favourable Opinion