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



Status:Recruiting
Conditions:High Blood Pressure (Hypertension), High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:1/13/2019
Start Date:May 2015
End Date:December 2022
Contact:Kristan Rollins, PharmD
Email:krollins@unither.com

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Intravenous Remodulin (Treprostinil) as Add-on Therapy for the Treatment of Persistent Pulmonary Hypertension of the Newborn: A Randomized, Placebo-Controlled, Safety and Efficacy Study

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).

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.

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)
We found this trial at
23
sites
231 E Chestnut St
Louisville, Kentucky 40202
(502) 629-6000
Principal Investigator: Dan Stewart, MD
Phone: 502-629-5038
Kosair Children's Hospital For more than a century, Kosair Children's Hospital and its predecessor hospitals...
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Ann Arbor, MI 48109Bus: -
Ann Arbor, Michigan 48109
Principal Investigator: Steven M Donn, MD
Phone: 734-615-7840
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: Molly Ball, M.D.
Phone: 614-355-6627
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Columbus, OH
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Principal Investigator: Eugenia Pallotto, MD
Phone: 816-983-6378
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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Kansas City, MO
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Principal Investigator: Philipe Friedlich, MD
Phone: 323-361-5088
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Los Angeles, CA
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1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Principal Investigator: John Clearly, MD
Phone: 714-509-8735
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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Orange, CA
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3020 Childrens way
San Diego, California 92123
(858) 576-1700
Principal Investigator: Denise Suttner, MD
Phone: 858-966-1700
Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Lewis Romer, MD
Phone: 617-919-4456
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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Boston, Massachusetts 02210
Principal Investigator: Mary Mullen, MD
Phone: 617-919-4456
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Boston, MA
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1215 Lee Street
Charlottesville, Virginia 22908
Principal Investigator: Jonathan Swanson, MD
Phone: 434-243-9377
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Principal Investigator: Nicolas Porta, MD
Phone: 312-227-5024
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
Principal Investigator: David Riley, MD, MBA
Phone: 682-885-3395
Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Principal Investigator: Nidhy Varghese, MD
Phone: 832-824-1553
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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Jackson, Mississippi 39216
Principal Investigator: Renate Savich, MD
Phone: 601-815-3070
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Jackson, MS
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1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Principal Investigator: Sherry Courtney, MD
Phone: 501-364-7192
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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Miami, Florida 33155
Principal Investigator: Magaly Diaz-Barbosa, MD
Phone: 786-624-2590
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Usha Krishnan, MD
Phone: 212-305-5258
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Palo Alto, California 94305
Principal Investigator: Christine Johnson, MD
Phone: 650-723-8922
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350 W Thomas Rd
Phoenix, Arizona 85013
(602) 406-3000
Principal Investigator: Vinit Manuel, MD
Phone: 602-406-5861
St. Joseph's Hospital and Medical Center St. Joseph's is a nationally recognized center for quality...
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Saint Petersburg, Florida 33701
Principal Investigator: Alfred Asante-Korang, MD
Phone: 727-767-6468
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Principal Investigator: Kendra Smith, MD
Phone: 206-987-4558
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Principal Investigator: Mariam Said, MD
Phone: 202-476-6909
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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Wauwatosa, Wisconsin 53226
Principal Investigator: Girja Konduri, MD
Phone: 414-337-7171
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