Oak Hill Bio OHB-607-202 Footprints V1.0
Research type
Research Study
Full title
A Phase 2b, Multicenter, Randomized, Open-label, Controlled, 3-Arm Study 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
IRAS ID
258672
Contact name
Paul Clarke
Contact email
Sponsor organisation
Premacure AB
Eudract number
2018-001393-16
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 4 months, 22 days
Research summary
This is an open-label study. SHIRE is the sponsor of this study.
This study will be carried out in babies born extremely prematurely as they have a higher risk of chronic lung disease (CLD) and other complications, 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 haemorrhage or IVH) and vision complications that can affect eyesight called retinopathy of prematurity (ROP).
Current treatment for premature babies is standard neonatal care. This study will assess the safety and effectiveness of the drug SHP607-202, in preventing chronic lung disease (CLD) compared to standard neonatal care in extremely premature infants.
Extremely preterm infants have low Insulin-like Growth Factor 1 (IGF-1) levels, and this is a risk factor for CLD and other complications of extreme prematurity. By increasing serum IGF-1 levels via SHP607 (study drug) administration, we may reduce the incidence of CLD and other complications of extreme prematurity.
The study drug SHP607 has been tested in humans previously, is generally safe and is well tolerated. The drug was previously marketed in the US under a different name.
Approximately 600 babies born at between 23 and almost 28 weeks gestational age (GA), (ie 12-17 weeks early), in about 70 hospitals around the world will take part in this study. Any subject’s maximum duration of participation is expected to be approximately 15-17 months depending on their particular GA at birth.
A brief summary of procedures that will be carried out throughout the duration of the study are as follows; physical examination, vital signs, weight, length and head measurement, oxygen monitoring and respiratory support, nutritional support, ultrasound of head, vision and hearing examination, intravenous infusion of medications and nutrition, and blood tests.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
19/YH/0180
Date of REC Opinion
21 Jun 2019
REC opinion
Favourable Opinion