Mallinckrodt’s Phase IV registry for PPHN medicine starts enrolment
Mallinckrodt Pharmaceuticals has started patient enrolment in a Phase IV registry (PaTTerN) to evaluate INOMAX (nitric oxide) gas inhalation to treat persistent pulmonary hypertension of the newborn (PPHN).
The trial will be conducted in premature neonates whose gestational age is less than 34 weeks and in term, near-term neonates with a gestational age of more than 34 weeks.
INOMAX is indicated for oxygenation improvement and to minimise extracorporeal membrane oxygenation need in term and near-term neonates with pulmonary hypertension (PH)-associated hypoxic respiratory failure (HRF), in combination with ventilatory support.
During the Phase IV registry trial, the neonates will be receiving inhaled nitric oxide through invasive or non-invasive ventilator support at various clinical sites in the US.
Expected to be completed by 2022, the enrolment will see the addition of approximately 168 subjects in the trial.
Mallinckrodt executive vice-president and chief scientific officer Steven Romano said: "We are pleased to enrol the first patient in this multi-centre, observational registry, which will generate data and insights concerning inhaled nitric oxide use in pre-term neonates with pulmonary hypertension compared with term and near-term neonates with pulmonary hypertension.”
The primary outcome of the PaTTerN trial is the measure of incidence of subjects with a minimum of 25% oxygenation index or surrogate oxygenation index improvement, when compared to baseline and summarised by gestation age group.
Results obtained from the trial are expected to provide insights into the potential use of inhaled nitric oxide to control PH and improve oxygenation in pre-term neonates with PH-associated HRF, compared to term and near-term neonates with similar condition.
Image: An illustration depicting pulmonary hypertension. Photo: courtesy of BruceBlaus.