STP206 for the Prevention of Necrotizing Enterocolitis (NEC)

Completed · Phase 1

Conditions studied: Necrotizing Enterocolitis

In brief

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.

Key facts

Study ID

NCT01954017

Run by

Leadiant Biosciences, Inc.

People needed

103

Starts

2014-01-30

Expected to finish

2018-10-22

Last updated by the study team

2020-03-24

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Neonates with birth weights between 2000-500g for Part A and 1500-500g for Part B
• Ability to start treatment within four days after birth.
• Gestational age between 23 and 32 weeks at birth
• Obtaining of informed consent from the subject's mother after full understanding of the study purpose and procedures.
• Parents who agree to allow the Principal Investigator and his/her staff to follow the procedures and assessments required by the protocol

You may not qualify if…

• Infants with, or at high probability for, early onset sepsis (positive blood cultures or with clinical/histological chorioamnionitis with the expectation of empirical antimicrobial therapy for ≥5 days)
• Infants with persistent pulmonary hypertension of the newborn (PPHN)
• Congenital or chromosomal anomalies
• Congenital or acquired gastrointestinal pathology that preclude feeds soon after birth (e.g. cleft lip is not an exclusion criterion, but a duodenal atresia is)
• Infants in extremis to whom no further intensive care is offered by attending neonatologist (e.g., infant being provided only hospice/comfort care)
• Other conditions of the infant which, in the opinion of the attending neonatologist, preclude participation
• Positive maternal HIV status
• Participation in another interventional clinical trial
• For Part A of the study, the following additional exclusion criterion will apply:
• Small for gestational age neonates, i.e. neonates that weigh less that the 10th percentile for their gestational age according to the Estimated Fetal Weight Percentile Chart

Where it is running

• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Sheridan Clinical Research / Plantation General Hospital — Sunrise, Florida, United States
• Augusta University — Augusta, Georgia, United States
• NorthShore University HealthSystem — Evanston, Illinois, United States
• Southern Illinois University School of Medicine — Springfield, Illinois, United States
• Wesley Medical Center — Wichita, Kansas, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• WakeMed Health and Hospitals — Raleigh, North Carolina, United States
• Medical University South Carolina — Charleston, South Carolina, United States
• University of Tennessee — Memphis, Tennessee, United States
• The Medical Center of Plano — Plano, Texas, United States
• West Virginia University — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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