CompletedPhase 1

STP206 for the Prevention of Necrotizing Enterocolitis (NEC)

United States103 participantsStarted 2014-01-30

Plain-language 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.

Who can participate

Age range1 Day – 4 Days

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: 30 days after the last dose of blinded study treatment

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

Timeframe: 30 days after the last dose of blinded study treatment

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

Timeframe: 30 days after last administration of study drug

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

Timeframe: 30 days after last administration of study drug

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

Timeframe: 30 days after last administration of study drug

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

Timeframe: 30 days after last administration of study drug

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

Timeframe: 30 days after last administration of study drug

Trial details

NCT IDNCT01954017

SponsorLeadiant Biosciences, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-02-28

Results submitted2020-01-31

View on ClinicalTrials.gov More Necrotizing Enterocolitis trials

Who can participate

Age range1 Day – 4 Days

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: 30 days after the last dose of blinded study treatment

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

Timeframe: 30 days after the last dose of blinded study treatment

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

Timeframe: 30 days after last administration of study drug

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

Timeframe: 30 days after last administration of study drug

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

Timeframe: 30 days after last administration of study drug

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

Timeframe: 30 days after last administration of study drug

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

Timeframe: 30 days after last administration of study drug