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Completed Phase 1 Interventional Results available

STP206 for the Prevention of Necrotizing Enterocolitis (NEC)

ClinicalTrials.gov ID: NCT01954017

Public ClinicalTrials.gov record NCT01954017. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 11:56 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase Ib Randomized, Placebo Controlled Study of the Safety and Efficacy of Once Daily Dosing of STP206 in Premature Very Low Birth Weight and Extremely Low Birth Weight Neonates

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study is a sequential dose escalation study to assess the safety, tolerability, and preliminary NEC-preventative efficacy of two doses of STP206 versus control in very low birth weight and extremely low birth weight neonates.

Study identification

NCT ID
NCT01954017
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Leadiant Biosciences, Inc.
Industry
Enrollment
103 participants

Conditions and interventions

Interventions

Biological · Other

Eligibility (public fields only)

Age range
1 Day to 4 Days
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 30, 2014 (Actual)
Primary completion
Feb 28, 2018 (Actual)
Completion
Oct 22, 2018 (Actual)
Last update posted
Mar 24, 2020

2014 – 2018

United States locations

U.S. sites
13
U.S. states
11
U.S. cities
13
Facility City State ZIP Site status
Connecticut Children's Medical Center Hartford Connecticut 06106 —
Sheridan Clinical Research / Plantation General Hospital Sunrise Florida 33323 —
Augusta University Augusta Georgia 30912 —
NorthShore University HealthSystem Evanston Illinois 60201 —
Southern Illinois University School of Medicine Springfield Illinois 62769 —
Wesley Medical Center Wichita Kansas 67214 —
Beth Israel Deaconess Medical Center Boston Massachusetts 02215 —
Baystate Medical Center Springfield Massachusetts 01199 —
WakeMed Health and Hospitals Raleigh North Carolina 27610 —
Medical University South Carolina Charleston South Carolina 29425 —
University of Tennessee Memphis Tennessee 38163 —
The Medical Center of Plano Plano Texas 75075 —
West Virginia University Morgantown West Virginia 26506 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01954017, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 24, 2020 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01954017 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →