Safety and Efficacy Study in Infants With SBS
Research type
Research Study
Full title
A Multi-Center, Randomized Double-Blind, Three-Arm, Parallel-Group trial to assess the efficacy and safety of NTRA-9620 in infants with Short Bowel Syndrome (SBS) following surgical resection.
IRAS ID
205966
Contact name
Tal Atarot
Contact email
Sponsor organisation
Nutrinia Ltd.
Eudract number
2015-000181-60
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 9 months, 1 days
Research summary
The main purpose of the study is to learn more about the effects of NTRA-9620 (an oral form of the drug insulin) in infants less than 52 weeks old who have Short Bowel Syndrome (SBS). SBS is a malabsorption disorder, caused by decreased length or functionality of bowel, often following surgery.
NTRA-9620 is being developed to treat infants with SBS who have lost at least 30% of their small bowel. Patients with SBS need to receive much of their nutrition into their veins, called parenteral nutrition (PN) or intravenous (IV) feeding, because their intestines cannot yet process enough food for proper development.We want to learn if NTRA-9620 can help the intestines grow and mature, allowing them to absorb more nutrients and fluids, thereby reducing the need for PN/IV feeding. The insulin in NTRA-9620 is not thought to be absorbed into the body, but to act locally in the gut.
Approximately 150 children at up to 40 centers in Europe, USA, Canada and Israel will participate in this study.
Patients will be randomly assigned (like flipping a coin) to one of two doses of NTRA-9620 or placebo. During the 24-week treatment period, subjects will receive study medicine four times a day in addition to their normal care, whilst hospitalised and after being released home.
The daily PN and oral intake will be recorded, as will growth and development and subjects will be assessed weekly or once every two weeks for the treatment period. Subjects will continue to receive their normal care and feedings after the 24 week treatment period.
A study analysis of efficacy and safety will be conducted after all patient’s complete treatment.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
17/EE/0171
Date of REC Opinion
19 Jun 2017
REC opinion
Further Information Favourable Opinion