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Safety and Efficacy Study in Infant With SBS (GIFT)

Primary Purpose

Short Bowel Syndrome

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NTRA-9620
Placebo
Sponsored by
Elgan Pharma Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Short Bowel Syndrome

Eligibility Criteria

2 Weeks - 52 Weeks (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lucile Packard Children's Hospital Stanford
  • Connecticut Children's Hospital
  • University of Florida
  • Children's Mercy Hospital
  • Cincinnati Children's Hospital
  • Nationwide Children's Hospital
  • Texas Children's Hospital
  • Seattle Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

NTRA-9620-A

NTRA-9620-B

Placebo

Arm Description

NTRA-9620 Dose 1 To be dosed orally for 24 weeks, 4 times/day

NTRA-9620 Dose 2 To be dosed orally for 24 weeks, 4 times/day

Placebo To be dosed orally for 24 weeks, 4 times/day

Outcomes

Primary Outcome Measures

Percent Change in %PN/IV
Percent change in %PN/IV from baseline based on caloric intake

Secondary Outcome Measures

Full Information

First Posted
August 9, 2016
Last Updated
October 11, 2021
Sponsor
Elgan Pharma Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02865122
Brief Title
Safety and Efficacy Study in Infant With SBS
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision based on enrollment
Study Start Date
March 20, 2017 (Actual)
Primary Completion Date
March 22, 2018 (Actual)
Study Completion Date
March 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elgan Pharma Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Short Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NTRA-9620-A
Arm Type
Experimental
Arm Description
NTRA-9620 Dose 1 To be dosed orally for 24 weeks, 4 times/day
Arm Title
NTRA-9620-B
Arm Type
Experimental
Arm Description
NTRA-9620 Dose 2 To be dosed orally for 24 weeks, 4 times/day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo To be dosed orally for 24 weeks, 4 times/day
Intervention Type
Drug
Intervention Name(s)
NTRA-9620
Intervention Description
Oral daily dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral daily dose
Primary Outcome Measure Information:
Title
Percent Change in %PN/IV
Description
Percent change in %PN/IV from baseline based on caloric intake
Time Frame
baseline and end of treatment or 24 weeks, whichever occurs first

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Weeks
Maximum Age & Unit of Time
52 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Subject must be at least 28 weeks post-menstrual age and up to 52 weeks chronological age at enrollment. Subject weight must be at least 500 grams (17.6 ounces) at time of enrollment. 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 Subject has undergone any bowel lengthening procedure. Subject has a malabsorption disorder due to: congenital etiology (such as microvilli inclusion disease, tufting enteropathy) Untreated Hirchsprung's disease 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. Subjects with hyperinsulinemia. Subjects with unexplained or recurrent hypoglycemia with blood glucose ≤ 50 mg/dL within 48 hours of treatment initiation.
Facility Information:
Facility Name
Lucile Packard Children's Hospital Stanford
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Connecticut Children's Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Cincinnati Children's Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Safety and Efficacy Study in Infant With SBS

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