Phase 1
N=103
STP206 for the Prevention of Necrotizing Enterocolitis (NEC)
Necrotizing Enterocolitis
Bottom Line
View on ClinicalTrials.gov: NCT01954017 ↗Enrolled (actual)
103
Serious AEs
32.3%
Results posted
Mar 2020
Primary outcome: Primary: Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups — 7; 4; 7; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- STP206 (Biological); Control (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Leadiant Biosciences, Inc.
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups |
7; 4; 7; 3; 9; 5 | — |
| PRIMARY Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups |
5; 4; 7; 3; 7; 3 | — |
| PRIMARY Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups |
1; 0; 2; 1; 5; 2 | — |
| PRIMARY Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups |
0; 0; 3; 0; 2; 2 | — |
| PRIMARY Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups |
0; 0; 0; 0; 0; 1 | — |
| PRIMARY Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups |
1; 0; 0; 0; 0; 0 | — |
| PRIMARY Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups |
0; 0; 0; 0; 0; 1 | — |
| PRIMARY Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups |
1; 0; 0; 0; 0; 0 | — |
| PRIMARY Growth Assessment Classification in Low-Dose Treatment Groups |
8; 4; 9; 4; 9; 5 | — |
| PRIMARY Growth Assessment Classification in High-Dose Treatment Groups |
8; 4; 7; 4; 8; 4 | — |
| SECONDARY Number of Patients With Suspected Necrotizing Enterocolitis in Low-Dose Treatment Groups |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Patients With Suspected Necrotizing Enterocolitis in High-Dose Treatment Groups |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Patients With Sepsis in Low-Dose Treatment Groups |
0; 1; 0; 0; 1; 1 | — |
| SECONDARY Number of Patients With Sepsis in High-Dose Treatment Groups |
0; 0; 0; 0; 1; 0 | — |
| SECONDARY Number of Patients With Feeding Intolerance in Low-Dose Treatment Groups |
2; 1; 2; 0; 6; 2 | — |
| SECONDARY Number of Patients With Feeding Intolerance in High-Dose Treatment Groups |
0; 0; 0; 0; 4; 0 | — |
| SECONDARY Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups |
0; 0; 1; 1; 7; 3 | — |
| SECONDARY Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups |
0; 1; 1; 1; 1; 2 | — |
| SECONDARY Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups |
0; 1; 4; 0; 6; 0 | — |
| SECONDARY Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups |
1; 1; 0; 0; 1; 3 | — |
| SECONDARY Number of Patients With Bronchopulmonary Dysplasia in Low-Dose Treatment Groups |
1; 0; 1; 1; 6; 1 | — |
| SECONDARY Number of Patients With Bronchopulmonary Dysplasia in High-Dose Treatment Groups |
1; 0; 0; 0; 2; 1 | — |
| SECONDARY Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups |
8; 2; 7; 2; 5; 1 | — |
| SECONDARY Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups |
8; 0; 7; 1; 6; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01954017). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.