Safety and Efficacy Study in Infant With SBS

Short Bowel Syndrome Clinical Trial

— GIFT  

Official 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02865122
• Other study ID #: GIFT-02
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: March 20, 2017
• Est. completion date: March 22, 2018

Study information

• Verified date: October 2021
• Source: Elgan Pharma Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: March 22, 2018
• Est. primary completion date: March 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 52 Weeks

Eligibility

Inclusion Criteria

1. Subject must be at least 28 weeks post-menstrual age and up to 52 weeks chronological age at enrollment.

2. Subject weight must be at least 500 grams (17.6 ounces) at time of enrollment.

3. After major surgical resection leading to SBS, the subject has maximally 70% of expected bowel length preserved or an ostomy in place such that = 70% of the small bowel is available for nutrient absorption.

Exclusion Criteria

1. Subject has undergone any bowel lengthening procedure.

2. Subject has a malabsorption disorder due to:

• congenital etiology (such as microvilli inclusion disease, tufting enteropathy)

• Untreated Hirchsprung's disease

3. Uncontrolled systemic infection, acute gastroenteritis, pneumonia, cardiovascular or other abnormality including EKG findings that in the opinion of the investigator makes the infant unstable and at significant risk of not completing first 12 weeks of the study.

4. Subjects with hyperinsulinemia.

5. Subjects with unexplained or recurrent hypoglycemia with blood glucose = 50 mg/dL within 48 hours of treatment initiation.

Related Conditions & MeSH terms

• Short Bowel Syndrome
• Syndrome

Intervention

Drug:
• NTRA-9620
Oral daily dose
• Placebo
Oral daily dose

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital	Cincinnati	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	University of Florida	Gainesville	Florida
United States	Connecticut Children's Hospital	Hartford	Connecticut
United States	Texas Children's Hospital	Houston	Texas
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	Lucile Packard Children's Hospital Stanford	Palo Alto	California
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Elgan Pharma Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in %PN/IV	Percent change in %PN/IV from baseline based on caloric intake	baseline and end of treatment or 24 weeks, whichever occurs first