SHP633-304 Extension prospective study in Paediatric Patients with SBS
Research type
Research Study
Full title
A Prospective, Open-label, Long-term Safety and Efficacy Study of Teduglutide in Pediatric Patients with Short Bowel Syndrome Who Completed TED-C14-006
IRAS ID
219967
Contact name
Susan Hill
Contact email
Sponsor organisation
Shire Human Genetic Therapies Inc.
Eudract number
2016-000849-30
Clinicaltrials.gov Identifier
IND, 058213
Duration of Study in the UK
2 years, 9 months, 31 days
Research summary
Short Bowel Syndrome (SBS) is a life-long condition caused by loss of most of the small intestine that often leads to diarrhoea and poor growth. Patients with SBS need special fluids and nutrients in a bag, known as parenteral support (PS), given through the veins (IV).\nAlthough PS can provide nutritional support for patients with compromised fluid and nutritional status, it is also associated with serious complications, such as infections and liver damage.\nTreatment of both children and adults is focused on achieving adequate intestinal absorption to allow for minimisation or discontinuation of PS. Because children are at higher risk for intestinal failure-associated liver disease, reducing PS is far more urgent in this population.\nThis phase III extension study proposes to continue to investigate the safe and appropriate use of teduglutide in children and young adults who completed TED-C14-006 study. Teduglutide is already approved in US and Canada to treat SBS in adults and in the EU to treat both adults and children.\nThe purpose of this study is to test how safe and efficacious study medicine is when taken for a long period of time, and whether it will allow to lower the amount of PS patients are receiving. Eligible patients who agree to participate and sign Informed Consent Form will be attending study visits every 1-4 weeks during a study drug treatment cycle, and approx. every 12 weeks outside of these cycles over 3 years period. Patients will be required to have blood tests performed and possibly some extra investigations such as a colonoscopy or sigmoidoscopy. \nAbout 34 children, who were younger than 18 years of age at the time they started TED-C14-006 study, in about 7 countries, are expected to take part in this study.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
17/SC/0245
Date of REC Opinion
27 Jun 2017
REC opinion
Further Information Favourable Opinion