Remodulin as Add-on Therapy for the Treatment of Persistent Pulmonary Hypertension of the Newborn

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Persistent Pulmonary Hypertension of the Newborn

In brief

This study assessed the safety and treatment effect of intravenous (IV) Remodulin as an add-on therapy in neonates with persistent pulmonary hypertension of the newborn (PPHN).

Key facts

Study ID

NCT02261883

Run by

United Therapeutics

People needed

42

Starts

2015-07-29

Expected to finish

2023-05-17

Last updated by the study team

2024-03-05

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Parent(s) or legal guardian provided consent for the subject to participate
• Weight at least 2 kg at Screening
• Gestational age of ≥34 weeks and ≤14 days old at Screening
• Diagnosis of PPHN, which was either idiopathic in nature or associated with the following: meconium aspiration syndrome, pneumonia, respiratory distress syndrome, sepsis, birth hypoxia, perinatal encephalopathy, or unilateral congenital diaphragmatic hernia
• Currently requiring ventilator support
• Two consecutive oxygenation index (OI) of 15 or greater separated by at least 30 minutes, after receiving iNO for at least 3 hours
• Echocardiographic (ECHO) evidence of pulmonary hypertension with elevated right ventricle pressure
• Dedicated venous access for the administration of study drug (central line or peripherally inserted central venous catheter)

You may not qualify if…

• Previous or concurrent use of a phosphodiesterase-5 inhibitor, endothelin receptor antagonist, or prostanoid
• Significant congenital heart disease as detected by ECHO, minor valvular abnormalities, or expected transitional findings such as a patent foramen ovale, or patent ductus arteriosus.
• Clinically significant, untreated active pneumothorax at Screening
• Evidence of clinically significant bleeding at Screening
• Necrotizing enterocolitis (≥Bells stage II at Screening)
• Uncontrolled hypotension (mean systemic pressures ≤35 mmHg at Screening)
• Uncontrolled coagulopathy and / or untreated thrombocytopenia (<50,000 platelets/µL at Screening)
• History of severe (Grade 3 or 4) intracranial hemorrhage at Screening
• Currently receiving extracorporeal mechanical oxygenation (ECMO) or had immediate plans to initiate ECMO
• Expected duration on mechanical ventilation of <48 hours
• Life expectancy was less than 2 months or had a lethal chromosomal anomaly
• Contraindication to ECMO
• Bilateral congenital diaphragmatic hernia
• Active seizures at Screening
• Currently participating in another clinical drug study

Where it is running

• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Children's Hospital of Los Angeles — Los Angeles, California, United States
• Stanford Children's Hospital — Palo Alto, California, United States
• All Children's Hospital — St. Petersburg, Florida, United States
• Ann and Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• University of Mississippi Medical Center - Baston Children's Hospital — Jackson, Mississippi, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• Columbia University Medical Center — New York, New York, United States
• Nationwide Childrens Hospital — Columbus, Ohio, United States
• Cook Children's Medical Center — Fort Worth, Texas, United States
• University of Virginia Health Systems (UVA) — Charlottesville, Virginia, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• Children's Hospital of Wisconsin — Wauwatosa, Wisconsin, United States

Full record on ClinicalTrials.gov

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