ZP4207-17106 an extension study of Dasiglucagon in children with CHI
Research type
Research Study
Full title
An Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon for the Treatment of Children with Congenital Hyperinsulinism
IRAS ID
249715
Contact name
Indraneel (Indi) Banerjee
Contact email
Sponsor organisation
Zealand Pharma A/S
Eudract number
2017-004546-15
Clinicaltrials.gov Identifier
135869, IND
Duration of Study in the UK
2 years, 3 months, 5 days
Research summary
Congenital hyperinsulinism (CHI) is a rare and challenging disorder in which excessive insulin secretion by pancreas causes repeated and often severe hypoglycaemia (low blood sugar). Hypoglycaemia is the main risk of CHI as in severe cases can cause long-term neurological impairments.\nThe ZP4207-17106 study is an open-label study to evaluate the long-term safety and efficacy of Dasiglucagon in children with CHI.\nDasiglucagon is an investigational medicine (not yet approved by regulatory authorities) which is similar to glucagon, a type of hormone produced by the human body. Dasiglucagon has a form of solution and will be administered under the skin, through an infusion pump.\nIf the study medicine works as expected, it may help to reduce the amount and frequency of nutritional feeds patients with CHI requires, while avoiding hypoglycaemia, which could substantially reduce the disease burden in this patients.\nEligible patients will be age 5 weeks to 12 years old, with confirmed diagnose of CHI, who completed the treatment period in one of the lead-in trial (ZP4207-17103 or ZP4207-17109) and in the opinion of study doctor would benefit from continued treatment with study medicine. \nThe study consists of 3 phases: Baseline (the End of Treatment visit in the lead-in trial will serve as the baseline visit), Treatment Period, and 12 weeks follow up period. \nDuring the treatment period all patients will receive Standard of Care plus Dasiglucagon treatment at home. Patients will continue to receive dasiglucagon at the same dose level as in the previous, lead-in study.\nAfter the Baseline Visit patients will attend visits to the study centre at Months 1, 3, and 6, and every 3 months after that. Additional visits to complete all required procedures, may be required.\nIn addition, the study doctor will contact parent/guardian monthly, by telephone, in between scheduled site visits.\nPatients will remain in the study and receive the study treatment until dasiglucagon receives approval in United Kingdom (UK) or until approximately the end of year 2020, whichever occurs first. \nDuring the study patients will undergo assessments which will include blood tests, electrocardiogram (ECG), echocardiogram and blood sugar monitoring.\nApproximately 30 children from up to 11 study centres in UK, Germany and USA will take part in this extension study.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
18/YH/0265
Date of REC Opinion
24 Aug 2018
REC opinion
Further Information Favourable Opinion