Phase 3 Pulmonary Hypertension Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• A parent or legal guardian must have signed a consent form, and children old enough to do so must have given their written agreement to take part
• Children from newborn up to (but not including) 18 years of age at the time consent was signed
• Children who have been diagnosed with severe pulmonary arterial hypertension (a serious condition where blood pressure in the lungs is very high) that requires treatment with a specific type of medication given through an infusion (prostacyclin)
• Children whose lung blood pressure condition has been confirmed by a heart procedure called a right heart catheterisation, showing specific pressure and resistance readings — or, for newborns and infants where that procedure is not possible for medical reasons, confirmation by an ultrasound of the heart (echocardiogram) is sufficient (confirm with trial site)
• Children who have either never received prostacyclin treatment before, or who have previously received a related medication called treprostinil given under the skin or through a vein
• Children who cannot become pregnant for physical/biological reasons, or, if pregnancy is possible: those who have a negative pregnancy test, are not breastfeeding, and if sexually active, agree to use two reliable forms of contraception throughout the study and for at least 30 days after the last dose

Who may not be able to join:

• Children who are known to have had a bad reaction or intolerance to prostacyclin medications
• Children whose high lung blood pressure is caused by a condition other than those specified for this trial
• Children who have a heart defect that has not been surgically repaired, if surgery is planned within the next 5 months
• Children who have been diagnosed with any lung disease
• Children who have had a sudden, serious worsening of heart failure within the 30 days before screening
• Children who have had a certain heart procedure (atrial septostomy or Potts shunt) within the 6 months before screening
• Children with abnormal blood or laboratory test results that would make starting or continuing the study medication unsafe
• Children with moderate to severe liver problems, including significantly raised liver enzyme levels or a specific classification of liver disease (confirm with trial site)
• Children who are pregnant or breastfeeding
• Children with certain blood disorders, such as severe anaemia or low white blood cell counts
• Children with a history of substance use disorder, unless there is documented proof of at least one year of no substance use
• Children with any other serious medical, psychiatric, or laboratory condition that the trial doctor believes would make participation unsafe or affect the trial results
• Children who have taken part in another clinical trial of an experimental drug or device within the previous 30 days, or within 5 half-lives of that drug — whichever period is longer
• Children who are not able to manage the pump and infusion equipment themselves, unless a parent, family member, or guardian in the household is able to take over that responsibility, or unless the child is being treated in a hospital setting

Important: Always verify eligibility with the trial site directly before applying.