CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 103 enrolled
Drug / intervention
STP206 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01954017
NCT01954017Phase 1Completed
CompareCT.gov

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

Leadiant Biosciences, Inc.·interventional·Posted Oct 1, 2013·Updated Mar 24, 2020

In Brief

A Phase 1 clinical trial evaluating STP206 and Control for Necrotizing Enterocolitis. Completed, enrolled 103 participants across 13 sites.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNecrotizing Enterocolitis
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 1, 2013
Enrollment StartJan 30, 2014
Primary CompletionFeb 28, 2018
Study CompletionOct 22, 2018
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 12.8 years ago

Interventions

STP206biological

Live Biotherapeutic

Controlother

Sterile Water