19-375 - A Clinical Efficacy and Safety Study of SHP607 in Preventing Chronic Lung Disease in Extremely Premature InfantsStatus: open
A Phase 2b, Multicenter, Randomized, Open-label, Controlled, 3-ArmStudy to Evaluate the Clinical Efficacy and Safety of SHP607 in Preventing Chronic Lung Disease Through 12 Months Corrected Age Compared to Standard Neonatal Care in Extremely Premature Infants
Treatment for Prevention of Chronic Lung Disease
The purpose of this research study is for an investigational drug called mecasermin rinfabate (rhIGF-1/rhIGFBP-3) or SHP607 used for extremely premature infants. Infants born prematurely have a higher risk of chronic (long-term) lung disease (CLD) and other complications (problems), which may result from low levels of certain hormones called growth factors. These complications may include a lung disorder called bronchopulmonary dysplasia (BPD), as well as other disorders such as bleeding in the brain (called intraventricular hemorrhage or IVH) and vision complications that can affect eyesight called retinopathy of prematurity (ROP). The purpose of this study is to determine if SHP607 can reduce the risk of CLD in babies born prematurely, compared to a group of premature babies that receives standard care (and does not receive SHP607)
SponsorsThis trial is sponsored by Shire Group of Companies.
Providers Associated With This Trial
- Fabien G. Eyal, M.D., Ph.DNeonatologistLouise Lenoir Locke Professor of Neonatology; Chief of the Division of Neonatology; Professor of Pediatrics