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 range

1 Day – 4 Days

Sex

ALL

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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 range

1 Day – 4 Days

Sex

ALL

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)

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