Safety and Efficacy Study in Infant With SBS
- Registration Number
- NCT02865122
- Lead Sponsor
- Elgan Pharma Ltd.
- Brief Summary
The objective of this clinical study is to evaluate the efficacy and safety of NTRA-9620 compared with placebo in pediatric subjects (aged 28 weeks postmenstrual age to 52 weeks old) with SBS following surgical resection
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo To be dosed orally for 24 weeks, 4 times/day NTRA-9620-A NTRA-9620 NTRA-9620 Dose 1 To be dosed orally for 24 weeks, 4 times/day NTRA-9620-B NTRA-9620 NTRA-9620 Dose 2 To be dosed orally for 24 weeks, 4 times/day
- Primary Outcome Measures
Name Time Method Percent Change in %PN/IV baseline and end of treatment or 24 weeks, whichever occurs first Percent change in %PN/IV from baseline based on caloric intake
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Lucile Packard Children's Hospital Stanford
🇺🇸Palo Alto, California, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Connecticut Children's Hospital
🇺🇸Hartford, Connecticut, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Cincinnati Children's Hospital
🇺🇸Cincinnati, Ohio, United States
University of Florida
🇺🇸Gainesville, Florida, United States