Not currently recruiting at University of California Health

A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants

a study on Bronchopulmonary Dysplasia Dysplasia Chronic Lung Disease of Prematurity Intraventricular Hemorrhage Retinopathy of Prematurity Premature Birth

Summary

Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Meena Garg (ucla)

Description

Summary

The purpose of this study is to determine if an investigational drug can prevent Bronchopulmonary Dysplasia, reducing the burden of chronic lung disease in extremely premature infants, as compared to extremely premature infants receiving standard neonatal care alone.

Official Title

A Phase 2b, Multicenter, Randomized, Open-label, Two-Arm Study to Evaluate the Clinical Efficacy and Safety of OHB-607 Compared to Standard Neonatal Care for the Prevention of Bronchopulmonary Dysplasia, the Most Common Cause of Chronic Lung Disease of Prematurity

Keywords

Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity, Intraventricular Hemorrhage, Retinopathy of Prematurity (ROP), Lung Diseases, Retinopathy of Prematurity, Premature Birth, Hemorrhage, Mecasermin, OHB-607

Eligibility

You can join if…

  1. Written informed consents and/or assents must be signed and dated by the participant's parent(s) prior to any study related procedures. The informed consent and any assents for underage parents must be approved by the IRB/IEC (in accordance with local regulations).
  2. Written informed consents and/or assents must be signed and dated by the participant's birth mother prior to providing study-related information related to birth mother medical history, pregnancy and the birth of the participant. The informed consent and any assents for underage birth mothers must be approved by the IRB/IEC (in accordance with local regulations).
  3. Subjects must be between 23 weeks +0 days and 27 weeks +6 days GA, inclusive.

You CAN'T join if...

  1. Detectable major (or severe) congenital malformation identified before randomization.
  2. Known or suspected chromosomal abnormality, genetic disorder, or syndrome, identified before randomization, according to the investigator's opinion.
  3. Hypoglycemia at Baseline (blood glucose less than (<) 45 milligrams per deciliter [mg/dL] or 2.5 milli moles per liter [mmol/L]) which persists in spite of glucose supplementation, to exclude severe congenital abnormalities of glucose metabolism.
  4. Clinically significant neurological disease identified before randomization according to cranial ultrasound (hemorrhages confined to the germinal matrix are allowed) and investigator's opinion.
  5. Any other condition or therapy that, in the investigator's opinion, may pose a risk to the participant or interfere with the participant's potential compliance with this protocol or interfere with interpretation of results.
  6. Current or planned participation in a clinical study of another investigational study treatment, device, or procedure (participation in non-interventional studies is permitted on a case-by-case basis).
  7. The participant or participant's parent(s) is/are unable to comply with the protocol or is unlikely to be available for long-term follow-up as determined by the investigator.
  8. Birth mother with active COVID-19 infection at birth or a history of severe COVID-19 infection (requiring intensive care hospitalization) during pregnancy.

Locations

  • LAC USC Medical Center in progress, not accepting new patients
    Los Angeles California 90033-1804 United States
  • University of Oklahoma Health Sciences Center in progress, not accepting new patients
    Oklahoma City Oklahoma 73104 United States
  • Medical University of South Carolina Children Hospital accepting new patients
    Charleston South Carolina 29425-8908 United States

Lead Scientist at University of California Health

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
OHB Neonatology Ltd.
ID
NCT03253263
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 338 study participants
Last Updated