Status:
TERMINATED
Remodulin as Add-on Therapy for the Treatment of Persistent Pulmonary Hypertension of the Newborn
Lead Sponsor:
United Therapeutics
Conditions:
Persistent Pulmonary Hypertension of the Newborn
Eligibility:
All Genders
1-14 years
Phase:
PHASE2
Brief Summary
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).
Detailed Description
This study was designed to investigate if the addition of Remodulin reduced the rate of clinical worsening (defined as the need for additional treatment targeting PPHN, need for extracorporeal mechani...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
July 29 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2023
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT02261883
Start Date
July 29 2015
End Date
May 17 2023
Last Update
March 5 2024
Active Locations (14)
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1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
2
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
3
Stanford Children's Hospital
Palo Alto, California, United States, 94304
4
All Children's Hospital
St. Petersburg, Florida, United States, 33701