Safety and Efficacy Study in Infant With SBS

NCT02865122 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: GIFT-02
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 8

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

Conditions

Short Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

NTRA-9620-A

EXPERIMENTAL

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

Drug: NTRA-9620

NTRA-9620-B

EXPERIMENTAL

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

Drug: NTRA-9620

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

NTRA-9620 DRUG

Oral daily dose

NTRA-9620-A; NTRA-9620-B

Placebo DRUG

Oral daily dose

Placebo

Eligibility Criteria

• Age: 2 Weeks - 52 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Subject has undergone any bowel lengthening procedure.
• Subject has a malabsorption disorder due to:
• 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.

Sponsors & Collaborators

• Elgan Pharma Ltd.: lead

Study Sites (8)

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

Location

Connecticut Children's Hospital

Hartford, Connecticut, 06106, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Short Bowel Syndrome

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Miki Olshansky, Chief Executive Officer
• Organization: Elgan Pharma Ltd.

Miki@elganpharma.com

972-4-6098600

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 12, 2016
• Study Start: March 20, 2017
• Primary Completion: March 22, 2018
• Study Completion: March 22, 2018
• Last Updated: October 12, 2021
• Results First Posted: October 12, 2021

Record last verified: 2021-10

Locations

US (8)