STP206 for the Prevention of Necrotizing Enterocolitis (NEC)

NCT01954017 | Completed Phase 1 Results DMC

• 1 other identifier: STP206-002
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Necrotizing Enterocolitis

Outcome Measures

Primary Outcomes (10)

• Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups

  The number and severity of adverse events, adverse events leading to study drug discontinuation, and number of deaths experienced by subjects randomized to the low-dose treatment groups

  30 days after the last dose of blinded study treatment

• Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups

  The number and severity of adverse events, adverse events leading to study drug discontinuation, and number of deaths experienced by subjects randomized to the low-dose treatment groups

  30 days after the last dose of blinded study treatment

• Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups

  Treatment-emergent adverse events experienced by subjects in low-dose treatment groups within 30 days of last exposure to study drug

  30 days after last administration of study drug

• Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups

  Treatment-emergent adverse events experienced by subjects in high-dose treatment groups within 30 days of last exposure to study drug

  30 days after last administration of study drug

• Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups

  Grade 3 treatment-emergent adverse events experienced by subjects in low-dose treatment groups within 30 days of last exposure to study drug

  30 days after last administration of study drug

• Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups

  Grade 3 treatment-emergent adverse events experienced by subjects in high-dose treatment groups within 30 days of last exposure to study drug

  30 days after last administration of study drug

• Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups

  Serious adverse events experienced by subjects in low-dose treatment groups within 30 days of last exposure to study drug

  30 days after last administration of study drug

• Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups

  Serious adverse events experienced by subjects in high-dose treatment groups within 30 days of last exposure to study drug

  30 days after last administration of study drug

• Growth Assessment Classification in Low-Dose Treatment Groups

  Accelerated growth area (AGA) is defined as both body weight (g) and head circumference (cm) are between 10th percentile and 90th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. Small for gestational age (SGA) SGA/Head-Spared is defined as body weight(g) is \<10th percentile, and head circumference(cm) is between 10th percentile and 90th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. SGA/Head-Symmetric is defined as both body weight(g) and head circumference(cm) are \<10th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. Large for gestational age (LGA) is defined as both body weight(g) and head circumference(cm) are \>90th percentile according to the growth percentile charts in Appendix D of Protocol v3.0.

  End of dosing/hospital discharge, up to 781 days

• Growth Assessment Classification in High-Dose Treatment Groups

  AGA is defined as both body weight (g) and head circumference (cm) are between 10th percentile and 90th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. SGA/Head-Spared is defined as body weight(g) is \<10th percentile, and head circumference(cm) is between 10th percentile and 90th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. SGA/Head-Symmetric is defined as both body weight(g) and head circumference(cm) are \<10th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0. LGA is defined as both body weight(g) and head circumference(cm) are \>90th percentile according to the growth percentile charts in Appendix D of Protocol v3.0.

  End of dosing/hospital discharge, up to 781 days

Secondary Outcomes (16)

• Number of Patients With Suspected Necrotizing Enterocolitis in Low-Dose Treatment Groups

  Start of dosing to 6 months

• Number of Patients With Suspected Necrotizing Enterocolitis in High-Dose Treatment Groups

  Start of dosing to 6 months

• Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups

  Start of dosing to 6 months

• Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups

  Start of dosing to 6 months

• Number of Patients With Sepsis in Low-Dose Treatment Groups

  Start of dosing to 6 months

Study Arms (2)

STP206

EXPERIMENTAL

Biological

Biological: STP206

Control

PLACEBO COMPARATOR

Sterile water

Other: Control

Interventions

STP206 BIOLOGICAL

Live Biotherapeutic

STP206

Control OTHER

Sterile Water

Control

Eligibility Criteria

• Age: 1 Day - 4 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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
• 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
• 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

Sponsors & Collaborators

• Leadiant Biosciences, Inc.: lead

Study Sites (13)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Sheridan Clinical Research / Plantation General Hospital

Sunrise, Florida, 33323, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62769, United States

Location

Wesley Medical Center

Wichita, Kansas, 67214, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

WakeMed Health and Hospitals

Raleigh, North Carolina, 27610, United States

Location

Medical University South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Tennessee

Memphis, Tennessee, 38163, United States

Location

The Medical Center of Plano

Plano, Texas, 75075, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: Scott Rodgers, MS, CCRA, ACRP-PM / Sr Director of Clinical Operations
• Organization: Leadiant Biosciences, Inc.

scott.rodgers@leadiant.com

301-670-1565

Study Officials

• Michael S Caplan, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2013
• First Posted: October 1, 2013
• Study Start: January 30, 2014
• Primary Completion: February 28, 2018
• Study Completion: October 22, 2018
• Last Updated: March 24, 2020
• Results First Posted: March 24, 2020

Record last verified: 2020-03

Locations

US (13)