Remodulin in PPHN, Version Am 2.0 30 Oct 2015
Research type
Research Study
Full title
Intravenous Remodulin (Treprostinil) as Add-on Therapy for the Treatment of Persistent Pulmonary Hypertension of the Newborn: A Randomized, Placebo-Controlled, Safety and Efficacy Study
IRAS ID
142157
Contact name
Christine Pierce
Contact email
Sponsor organisation
United Therapeutics Corporation
Eudract number
2013-004963-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 3 months, 26 days
Research summary
PPHN is a condition that some babies are born with where the blood pressure in their lungs is high and this can make breathing for them more difficult. PPHN can be caused by a condition called meconium aspiration, an infection or reduced oxygen at birth. Nitric Oxide is normally produced by our lungs and helps to keep the lung working by reducing the lung blood pressure. Not enough Nitric oxide may be made in babies with PPHN causing the blood pressure in the lungs to increase. These babies have difficulties with getting enough oxygen into their blood stream. Sometimes babies with PPHN do not respond to the initial treatments available. This purpose of this study is investigate whether the use of Remodulin in PPHN in addition to the usual treatments can help babies with the condition. Remodulin is approved by the Food and Drug Administration (FDA) in the United States to treat pulmonary arterial hypertension in adults but has not been approved for the treatment of PPHN. Remodulin works to help keep the blood vessels to the lungs open and working properly so there is less strain on the heart. This study will look at the safety and effect that the medicine may have on PPHN. In this study, about 70 newborn babies with PPHN will participate from up to 30 medical centers located throughout the United States and United Kingdom. Of the 70 newborn babies, a maximum of 30 with a diagnosis of PPHN associated with congenital diaphragmatic hernia (CDH) will be enrolled.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
15/LO/0082
Date of REC Opinion
13 Jan 2016
REC opinion
Further Information Favourable Opinion