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

  • STATUS
    Recruiting
  • End date
    Dec 6, 2022
  • participants needed
    70
  • sponsor
    United Therapeutics
Updated on 6 May 2022

Summary

This pilot study aims to assess the safety and treatment effect of acute dosing with IV Remodulin in neonates with persistent pulmonary hypertension of the newborn (PPHN).

Description

This study will enroll subjects with PPHN who do not show an adequate response to inhaled nitric oxide with the hypothesis that the addition of intravenous (IV) Remodulin will reduce the rate of clinical worsening as compared to standard of care. Additionally, this study aims to evaluate the treatment effect of Remodulin and better understand the dosing and pharmacokinetics in the neonatal population.

Details
Condition Persistent Pulmonary Hypertension of the Newborn
Treatment Placebo, IV Remodulin
Clinical Study IdentifierNCT02261883
SponsorUnited Therapeutics
Last Modified on6 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Parent(s) or guardian provides consent for the subject to participate, as per institutional policy
At least 2 kg at Screening
Gestational age ≥ 34 weeks and ≤ 14 days old at Screening
Diagnosis of PPHN, which is either idiopathic in nature or associated with the following: meconium aspiration syndrome (MAS), pneumonia, respiratory distress syndrome (RDS), sepsis, birth hypoxia, perinatal encephalopathy or unilateral congenital diaphragmatic hernia (CDH)
Currently requiring ventilator support
Receiving iNO with two OIs of 15 or greater separated by at least 30 minutes after receiving iNO for at least 3 hours
Echocardiographic 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 Criteria

Previous or concurrent use of a phosphodiesterase-5 inhibitor (PDE5i), endothelin receptor antagonist (ERA), or prostanoid
Significant congenital heart disease (CHD) as detected by ECHO (excluding presence of minor defects such as small secundum atrial septal defect (ASD), minor valvular abnormalities, or expected transitional findings such as a patent foramen ovale (PFO), or patent ductus arteriosus (PDA). Subjects with small muscular, restrictive ventricular septal defect (VSD) may be enrolled
Clinically significant, untreated active pneumothorax at Screening
Evidence of clinically significant bleeding
Necrotizing entercolitis; ≥ Bells stage II at Screening
Uncontrolled hypotension; mean systemic pressures ≤ 35 mmHg at Screening
Uncontrolled coagulopathy and / or untreated thrombocytopenia; defined as <50,000 platelets /µL at Screening
History of severe (Grade 3 or 4) intracranial hemorrhage
Currently receiving ECMO or has immediate plans to initiate ECMO
Expected duration on mechanical ventilation of less than 48 hours
Life expectancy is less than two months or has a lethal chromosomal anomaly
Contraindication to ECMO
Bilateral congenital diaphragmatic hernia
Active seizures at Screening
Currently participating in another clinical drug study (excluding observational registries)
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