Phase
Condition
Scleroderma
Williams Syndrome
Pulmonary Arterial Hypertension
Treatment
Treprostinil Palmitil
Placebo
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Males and females must be ≥ 18 to ≤ 80 years of age at the time of signing theinformed consent form (ICF).
Diagnosis of pulmonary hypertension (PH) associated with interstitial lung disease (ILD) (including idiopathic interstitial pneumonia [IIP], idiopathic pulmonaryfibrosis [IPF], connective tissue disease [CTD], sarcoidosis).
Male and female participants must use contraceptives that are consistent with localregulations regarding the methods of contraception for those participating inclinical studies.
Male participants:
Male participants who are not sterile, with female partners of childbearing potential, must be using effective contraception from Day 1 to at least 90 days after the last dose of study drug.
Male participants with women of child bearing potential (WOCBP) partner must use a condom in order to avoid potential exposure to embryo/fetus.
Female participants: Women must be postmenopausal (defined as no menses for 12months without an alternative medical cause), surgically sterile, (ie,hysterectomyand/or bilateral salpingo-oophorectomy) or using highly effective contraceptionmethods (ie, methods that alone or in combination achieve <1% unintended pregnancyrates per year when used consistently and correctly) from Day 1 to at least 90 daysafter the last dose of study drug.
Capable of giving signed informed consent that includes compliance with therequirements and restrictions listed in the ICF and in this protocol.
Exclusion
Exclusion Criteria:
Primary diagnosis of chronic obstructive pulmonary disease (COPD).
Allergy, or documented hypersensitivity or contraindication to TPIP or treprostinil (TRE) or mannitol (an excipient of the TPIP formulation).
Received or currently treated with riociguat, endothelin receptor antagonists,selexipag, phosphodiesterase 5 (PDE5) inhibitors and/or prostacyclin analogueswithin 30 days prior to Screening.
Started therapy with pirfenidone or nintedanib < 90 days prior to Screening, OR, ifalready receiving either medication, there is a dose change within 30 days ofScreening Visit.
Any known ventricular or supraventricular tachyarrhythmia (except for paroxysmalatrial fibrillation), and/or any symptomatic bradycardia.
History of heart disease including left ventricular ejection fraction (LVEF) ≤ 40%or clinically significant valvular, constrictive, or symptomatic atheroscleroticheart disease (eg, stable angina, myocardial infarction, etc).
Participation in a cardiopulmonary rehabilitation program within 30 days of thefirst Screening Visit. Participation in the maintenance program of a cardiopulmonaryrehabilitation program is allowed.
Acutely decompensated heart failure within 30 days of Screening Visit.
Active and current symptomatic coronavirus disease 2019 (COVID-19) and/or previousdiagnosis of moderate to severe disease, or hospitalization due to COVID-19.
Supplemental oxygen requirement > 10L/min at rest at Screening.
Exacerbation of underlying lung disease or active pulmonary or upper respiratoryinfection within 30 days of the first dose of study drug (may be rescreened atappropriate time).
Current or recent (past 30 days) lower respiratory tract infection (may berescreened at appropriate time).
Any form of congenital heart disease or congenital heart defect (repaired orunrepaired) other than a patent foramen ovale.
History of alcohol or drug abuse within 6 months prior to Screening.
Current use of cigarettes (as defined by Center for Disease Control (CDC)) ore-cigarettes: An adult who has smoked at least 100 cigarettes in his or her lifetimeand who currently smokes either every day or some days.
Participants who currently inhale marijuana (recreational or medical).
Acute or chronic impairment (other than dyspnea), limiting the ability to complywith study requirements, in particular with 6-minute walk test (6MWT) (eg, anginapectoris, claudication, musculoskeletal disorder, need for walking aids).
Study Design
Connect with a study center
ARG006
Villa Vatteone, Buenos Aires B1853AIK
ArgentinaSite Not Available
ARG003
Barracas, Ciudad Autónoma De BuenosAires C1280AEB
ArgentinaSite Not Available
ARG007
Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires C1425BNG
ArgentinaSite Not Available
ARG004
Villa Regina, Río Negro R8336
ArgentinaSite Not Available
ARG001
Rosario, Santa Fe S2013KDS
ArgentinaSite Not Available
ARG002
San Miguel De Tucumán, Tucumán T4000AXL
ArgentinaSite Not Available
ARG002
San Miguel de Tucuman, Tucumán T4000AXL
ArgentinaSite Not Available
ARG008
Buenos Aires, CI094AAD
ArgentinaSite Not Available
AUS003
Camperdown, New South Wales 2050
AustraliaSite Not Available
AUS005
Macquarie Park, New South Wales 2109
AustraliaSite Not Available
AUS001
Westmead, New South Wales 2145
AustraliaSite Not Available
AUS002
Milton, Queensland 4064
AustraliaSite Not Available
AUS004
South Brisbane, Queensland 4101
AustraliaSite Not Available
BEL001
Anderlecht, Brussels 1070
BelgiumSite Not Available
BEL003
Leuven, Vlaams Brabant 3000
BelgiumSite Not Available
BEL002
Liège, 4000
BelgiumSite Not Available
GER006
Heidelberg, Baden-Württemberg 69126
GermanySite Not Available
GER013
München, Bayern 80335
GermanySite Not Available
GER010
Gießen, Hessen 35392
GermanySite Not Available
GER005
Immenhausen, Hessen 34376
GermanySite Not Available
GER003
Essen, Nordrhein-Westfalen 45239
GermanySite Not Available
GER009
Homburg, Saarland 66424
GermanySite Not Available
GER001
Dresden, Sachsen 01307
GermanySite Not Available
GER008
Halle, Sachsen-Anhalt 06120
GermanySite Not Available
GER002
Berlin, 13125
GermanySite Not Available
GER012
Berlin, 14050
GermanySite Not Available
GER004
Munich, 81377
GermanySite Not Available
ITA003
Napoli, Campania 80131
ItalySite Not Available
ITA007
Modena, Emilia-Romagna 41124
ItalySite Not Available
ITA004
Milano, Lombardia 20123
ItalySite Not Available
ITA005
Milano, Lombardia 20122
ItalySite Not Available
ITA002
Monza, Lombardia 20900
ItalySite Not Available
ITA006
Rozzano, Lombardia 20089
ItalySite Not Available
ITA001
Palermo, Sicilia 90127
ItalySite Not Available
NZL001
Christchurch, Canterbury 8011
New ZealandSite Not Available
NZL002
Dunedin, Otago 9016
New ZealandSite Not Available
NZL003
Hamilton, Waikato 3204
New ZealandSite Not Available
USA014
Guaynabo, 00926
Puerto RicoSite Not Available
ESP007
Oviedo, Asturias 33011
SpainSite Not Available
ESP003
Palma de Mallorca, Baleares 07120
SpainSite Not Available
ESP001
Santander, Cantabria 39008
SpainSite Not Available
ESP005
Barcelona, 08907
SpainSite Not Available
ESP010
Barcelona, 08035
SpainSite Not Available
ESP002
Madrid, 28046
SpainSite Not Available
ESP008
Salamanca, 37007
SpainSite Not Available
ESP009
Santiago de Compostela, 15706
SpainSite Not Available
ESP006
las Palmas de Gran Canaria, 35010
SpainSite Not Available
GBR007
Bath, Avon BA1 3NG
United KingdomSite Not Available
GBR008
Cambridge, Cambridgeshire CB2 0AY
United KingdomSite Not Available
GBR003
Glasgow, Lanarkshire G81 4HX
United KingdomSite Not Available
GBR002
Salford, Lancashire M6 8HD
United KingdomSite Not Available
GBR004
London, London, City Of W12 0HS
United KingdomSite Not Available
GBR005
London, London, City Of SW3 6HP
United KingdomSite Not Available
GBR006
Edinburgh, Midlothian EH16 4SA
United KingdomSite Not Available
GBR001
Sheffield, Yorkshire S10 2JF
United KingdomSite Not Available
USA007
Los Angeles, California 90033-5313
United StatesSite Not Available
USA008
Aurora, Colorado 80045-2541
United StatesSite Not Available
USA010
Altamonte Springs, Florida 32701-4817
United StatesSite Not Available
USA017
Tampa, Florida 33606
United StatesSite Not Available
USA002
Atlanta, Georgia 30309-1281
United StatesSite Not Available
USA002
Austell, Georgia 30106-1110
United StatesSite Not Available
USA013
Indianapolis, Indiana 46260-1992
United StatesSite Not Available
USA003
Kansas City, Kansas 66160-8500
United StatesSite Not Available
USA015
Boston, Massachusetts 02111-1552
United StatesSite Not Available
USA006
Springfield, Massachusetts 01101
United StatesSite Not Available
USA016
Mineola, New York 11714
United StatesSite Not Available
USA001
Houston, Texas 77070
United StatesSite Not Available
USA004
McKinney, Texas 75069-8085
United StatesSite Not Available
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