What is the Purpose of this Study?
Babies born prematurely often have problems with their lungs and breathing. The purpose of this study is to determine whether an experimental drug called mecasermin rinfabate (OHB-607) can decrease the risk of breathing problems and lung disease in premature babies. Researchers are particularly interested in a lung disease called bronchopulmonary dysplasia (BPD), which is a form of chronic lung disease that affects premature newborns. In BPD, the lungs are damaged, causing breakdown of the tissue (dysplasia) in the tiny air sacs of the lung (alveoli). The study aims to determine whether OHB-607 can reduce the risk of breathing problems due to BPD, as well as reduce the risk of other problems that premature babies may have. Researchers will also evaluate the safety and side effects (if any) of OHB-607. OHB-607 is a growth factor called insulin-like growth factor 1 (IGF-1). Growth factors are substances that the body makes to help it grow normally; babies who are born prematurely have very low levels of IGF-1.
Eligibility
- 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.
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
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