Safety and Efficacy Study in Infant With SBS

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-20

Study Completion Date

2018-03-22

Brief Summary

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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

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Detailed Description

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Conditions

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Short Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NTRA-9620-A

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

Group Type EXPERIMENTAL

NTRA-9620

Intervention Type DRUG

Oral daily dose

NTRA-9620-B

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

Group Type EXPERIMENTAL

NTRA-9620

Intervention Type DRUG

Oral daily dose

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral daily dose

Interventions

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NTRA-9620

Oral daily dose

Intervention Type DRUG

Placebo

Oral daily dose

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

2 Weeks

Maximum Eligible Age

52 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No