Necrotizing EnterocolitisPhase 2NCT02472769
IBP-9414 for the Prevention of Necrotizing Enterocolitis
A Phase 2 study testing IBP-9414 in people with Necrotizing Enterocolitis, run by Infant Bacterial Therapeutics at 15 sites in United States.
Trial summary
Two different dose levels will be evaluated in two different birth weight categories, compared to placebo with regards to safety and tolerability. Read more about this study
- Who is it for?
- Ages Up to 48 hours
- Conditions the study is for
- Necrotizing Enterocolitis
- What is being tested?
- IBP-9414
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 15 sitesUnited States
- Study dates
- 27 May 2016to 7 Aug 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 48 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age ≤32 weeks
- Birth weight: a) ≤ 2,000 g and b) ≤ 1,000 g.
- < 48 hours of age.
- Written informed consent from the patient's legally authorized representative(s).
Who cannot join
- Participation in an additional interventional clinical trial in which an investigational drug will be administered.
- Infants in extremis to whom no further intensive care is offered by attending neonatologist (e.g., infant being provided only hospice/comfort care).
- Congenital or acquired gastrointestinal pathology.
- Other conditions of the infant, which in the opinion of the attending neonatologist, preclude participation.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Kings County Hospital Center
Brooklyn, New York, 11203
Duke University Medical Center
Durham, North Carolina, 27710
University Florida Health
Gainesville, Florida, 32610-0296
Jackson Madison County General Hospital
Jackson, Tennessee, 38301
Wolfson Children´s Hospital
Jacksonville, Florida, 32207
UF Health Jacksonville
Jacksonville, Florida, 32209
Univ. Arkansas Medical Sciences
Little Rock, Arkansas, 72202
UCLA Medical Center
Los Angeles, California, 90095
Jackson Memorial Hospital
Miami, Florida, 33136
Timpanogos Regional Hospital
Orem, Utah, 84057
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102
Einstein Medical Center of Philadelphia
Philadelphia, Pennsylvania, 19141
Memorial Hospital of South Bend
South Bend, Indiana, 46601
Wesley Medical Center
Wichita, Kansas, 67214
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: A Randomized, Double Blind, Parallel-group, Dose Escalation Placebo-controlled Multicenter Study to Investigate the Safety and Tolerability of IBP-9414 Administered in Preterm Infants.
Two different dose levels will be evaluated in two different birth weight categories, compared to placebo with regards to safety and tolerability.
- Conditions
- Necrotizing Enterocolitis
- Being tested
- IBP-9414, Placebo
- Medical subject headings
- Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBP-9414Drug
PlaceboDrug
Sterile water
| Study group | Role | What they receive |
|---|---|---|
| IBP-9414 | Active comparator | IBP-9414 Oral Daily Receives: Drug: IBP-9414 |
| Placebo | Placebo comparator | Sterile water Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of IBP-9414 as the observed number of adverse events (AE) and serious adverse events (SAE)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2015 (estimated)
- Study start27 May 2016
- Primary completion7 Aug 2017
- Study completion7 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing EnterocolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Infant Bacterial Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Josef Neu, MD, Principal investigator, University of Florida College of Medicine, Gainsville, FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02472769
- Sponsor's protocol ID
- IBP-9414-010
- Status last verified
- Jan 2017
- First submitted
- 2 Jun 2015
- Last updated
- 29 Dec 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Parallel-group, Dose Escalation Placebo-controlled Multicenter Study to Investigate the Safety and Tolerability of IBP-9414 Administered in Preterm Infants.
- ClinicalTrials.gov ID
- NCT02472769
- Acronym / sponsor ID
- IBP-9414-010
- Conditions
- Necrotizing Enterocolitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Infant Bacterial TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 27 May 2016 (actual)
- Primary completion
- 7 Aug 2017 (actual)
- Study completion
- 7 Aug 2017 (actual)
- First posted
- 16 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Two different dose levels will be evaluated in two different birth weight categories, compared to placebo with regards to safety and tolerability.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBP-9414 | Active comparator | Drug: IBP-9414IBP-9414 Oral Daily |
| Placebo | Placebo comparator | Drug: PlaceboSterile water |
Who may qualify
- Ages
- Up to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Gestational age ≤32 weeks
- Birth weight: a) ≤ 2,000 g and b) ≤ 1,000 g.
- < 48 hours of age.
- Written informed consent from the patient's legally authorized representative(s).
Key exclusion criteria (4 listed)
- Participation in an additional interventional clinical trial in which an investigational drug will be administered.
- Infants in extremis to whom no further intensive care is offered by attending neonatologist (e.g., infant being provided only hospice/comfort care).
- Congenital or acquired gastrointestinal pathology.
- Other conditions of the infant, which in the opinion of the attending neonatologist, preclude participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBP-9414 | Drug | IBP-9414 |
| PlaceboSterile water | Drug | Placebo |
Primary outcome
Safety and Tolerability of IBP-9414 as the observed number of adverse events (AE) and serious adverse events (SAE)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2017.
Related trials for Necrotizing Enterocolitis
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC) - Clinical Study
Necrotizing Enterocolitis (NEC), Necrotizing Enterocolitis of Newborn
Active, not recruitingObservational study
Early Predictors of Necrotizing Enterocolitis in Neonates
Necrotizing Enterocolitis
Recruiting
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
Very Preterm Infant, Necrotizing Enterocolitis (NEC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josef Neu, MD principal investigator
University of Florida College of Medicine, Gainsville, FL
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IBP-9414 in people with Necrotizing Enterocolitis, run by Infant Bacterial Therapeutics at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of IBP-9414 as the observed number of adverse events (AE) and serious adverse events (SAE) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2017.