Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
Launched by UNITED THERAPEUTICS · May 25, 2021
Trial Information
Current as of July 22, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
Study RIN-PF-302 is a Phase 3, multicenter, open-label extension (OLE) study for eligible subjects who completed Study RIN-PF-301 or Study RIN-PF-303 to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis (IPF). Following OLE entry, subjects will return at Week 4, Week 12, and every 12 weeks thereafter for up to 6 years or until the subject prematurely discontinues study treatment due an adverse event (AE)/serious adverse event (SAE) or other reason, inhaled treprostinil becomes commercially available for IPF, or the study is...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Subject gives voluntary informed consent to participate in the study.
- • 2. The subject participated in Study RIN-PF-301 or Study RIN-PF-303 and remained on study drug and completed all scheduled study visits or was enrolled in Study RIN-PF-301 or Study RIN-PF-303 at the time that the study or study subject was discontinued by the Sponsor.
- • 3. Women of childbearing potential must be non-pregnant (as confirmed by a urine pregnancy test at OLE Entry Visit and Baseline) and non-lactating, and will abstain from intercourse (when it is in line with their preferred and usual lifestyle) or use 2 medically acceptable, highly effective forms of contraception for the duration of the study, and at least 30 days after discontinuing study drug.
- • 4. Males with a partner of childbearing potential must use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.
- • 5. In the opinion of the Investigator, the subject is able to communicate effectively with study personnel, and is considered reliable, willing, and likely to be cooperative with protocol requirements, including attending all study visits.
- Exclusion Criteria:
- • 1. Subject is pregnant or lactating.
- • 2. In the opinion of the Investigator, enrollment in Study RIN-PF-302 would represent a risk to the subject's overall health.
About United Therapeutics
United Therapeutics is a leading biotechnology company dedicated to addressing the unmet medical needs of patients with life-threatening conditions, particularly in the fields of pulmonary arterial hypertension and organ transplantation. Founded in 1996, the company focuses on the development and commercialization of innovative therapies that enhance patient quality of life and extend survival. With a robust pipeline and a commitment to scientific excellence, United Therapeutics partners with healthcare providers, researchers, and advocacy groups to drive advancements in treatment options and improve outcomes for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Philadelphia, Pennsylvania, United States
Kansas City, Kansas, United States
Minneapolis, Minnesota, United States
Houston, Texas, United States
Milwaukee, Wisconsin, United States
Charleston, South Carolina, United States
Boston, Massachusetts, United States
Bronx, New York, United States
Saint Louis, Missouri, United States
Brussels, , Belgium
Maywood, Illinois, United States
Chicago, Illinois, United States
Detroit, Michigan, United States
Rochester, New York, United States
Oklahoma City, Oklahoma, United States
Dallas, Texas, United States
Malaga, , Spain
New Orleans, Louisiana, United States
Stanford, California, United States
Philadelphia, Pennsylvania, United States
Atlanta, Georgia, United States
Barcelona, , Spain
Santander, , Spain
Houston, Texas, United States
Boston, Massachusetts, United States
Cleveland, Ohio, United States
Falls Church, Virginia, United States
Nashville, Tennessee, United States
Jacksonville, Florida, United States
Tucson, Arizona, United States
Los Angeles, California, United States
Weston, Florida, United States
Gainesville, Florida, United States
Madrid, , Spain
Boston, Massachusetts, United States
Greenville, North Carolina, United States
Madrid, , Spain
Jacksonville, Florida, United States
Westmead, , Australia
Hamilton, Ontario, Canada
Granada, , Spain
Ashkelon, , Israel
Rennes, , France
Birmingham, Alabama, United States
Albuquerque, New Mexico, United States
Liège, , Belgium
Baltimore, Maryland, United States
Haifa, , Israel
Kfar Saba, , Israel
Leuven, , Belgium
Jerusalem, , Israel
Denver, Colorado, United States
Chermside, Queensland, Australia
Seoul, , Korea, Republic Of
Barcelona, , Spain
Madrid, , Spain
Antwerpen, , Belgium
Portland, Oregon, United States
Cincinnati, Ohio, United States
Camperdown, , Australia
Liège, , Belgium
Taipei, , Taiwan
L´Hospitalet De Llobregat, Barcelona, Spain
Louisville, Kentucky, United States
Orlando, Florida, United States
Shreveport, Louisiana, United States
Murray, Utah, United States
New Taipei City, , Taiwan
Roma, , Italy
Melbourne, Victoria, Australia
Columbus, Ohio, United States
Amiens, , France
Palm Springs, California, United States
Chesterfield, Missouri, United States
Santiago De Compostela, , Spain
Rock Hill, South Carolina, United States
Oviedo, Asturias, Spain
Trois Rivières, Quebec, Canada
The Woodlands, Texas, United States
Macquarie Park, New South Wales, Australia
Yvoir, Namur, Belgium
Indianapolis, Indiana, United States
Gainesville, Florida, United States
Kaohsiung, , Taiwan
Winston Salem, North Carolina, United States
New Hyde Park, New York, United States
Charlottesville, Virginia, United States
Macquarie University, New South Wales, Australia
Dallas, Texas, United States
Seongnam Si, Gyeonggido, Korea, Republic Of
Murcia, , Spain
Greensboro, North Carolina, United States
Incheon, , Korea, Republic Of
South Brisbane, Queensland, Australia
Phoenix, Arizona, United States
Ciudad Autónoma De Buenos Aires, , Argentina
Cleveland, Ohio, United States
Québec, , Canada
Modena, Emilia Romagna, Italy
Louisville, Kentucky, United States
Palma De Mallorca, Baleares, Spain
Hamilton, Waikato, New Zealand
Madison, Wisconsin, United States
Richmond, Virginia, United States
Salt Lake City, Utah, United States
Jacksonville, Florida, United States
Tampa, Florida, United States
Forlì, , Italy
Columbia, South Carolina, United States
Antwerpen, , Belgium
Chermside, Queensland, Australia
Kissimmee, Florida, United States
Rochester, Minnesota, United States
Omaha, Nebraska, United States
Knoxville, Tennessee, United States
Monterrey, Nuevo León, Mexico
Lima, , Peru
Phoenix, Arizona, United States
Newport Beach, California, United States
Saint Petersburg, Florida, United States
Anderlecht, Brussels, Belgium
Tours, Indre Et Loire, France
Mckinney, Texas, United States
Franklin, Arizona, United States
Malaga, Málaga, Spain
Aarhus N, , Denmark
Seongnam Si, Gyeonggido, Korea, Republic Of
Ramat Gan, Tel Aviv, Israel
Jerusalem, Yerushalayim, Israel
Mar Del Plata, Buenos Aires, Argentina
Rehovot, Hamerkaz, Israel
Mcallen, Texas, United States
Ancona, , Italy
Roma, Lazio, Italy
Jackson, Mississippi, United States
Sacramento, California, United States
Ann Arbor, Michigan, United States
Atlanta, Georgia, United States
Talca, Maule, Chile
Quillota, Valparaiso, Chile
Petah Tiqva, , Israel
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Kaohsiung, , Taiwan
Tel Aviv, , Israel
Rosenheim, Bayern, Germany
Dongjak Gu, Seoul Teugbyeolsi, Korea, Republic Of
Ajax, Ontario, Canada
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Córdoba, , Argentina
Mendoza, , Argentina
Santiago, Metropolitana, Chile
Santiago, Región Metropolitana, Chile
Hellerup, , Denmark
Odense C, , Denmark
Bron, , France
Silver Spring, Maryland, United States
Rio Cuarto, , Argentina
Marseille, Bouches Du Rhône, France
Toulouse, Haute Garonne, France
Paris, , France
Siena, Toscana, Italy
Hadera, Haifa, Israel
Rotterdam, Zuid Holland, Netherlands
Royal Oak, Michigan, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Bobigny, , France
Reims, , France
Catania, Sicilia, Italy
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Christchurch, , New Zealand
Ciudad De Mexico, , Mexico
Antwerpen, , Belgium
Monterrey, Nuevo León, Mexico
Paris, , France
Milan, Lombardia, Italy
Heerlen, Limburg, Netherlands
Córdoba, , Argentina
San Miguel De Tucumán, Tucumán, Argentina
San Miguel De Tucumán, Tucumán, Argentina
Lima, , Peru
Trois Rivières, Quebec, Canada
Santiago, Región Metropolitana, Chile
Aalst, , Belgium
Ajax, Ontario, Canada
Caen, Calvados, France
Rouen, Seine Maritime, France
Löwenstein, Baden Württemberg, Germany
München, Bayern, Germany
Essen, Nordrhein Westfalen, Germany
Coswig, Sachsen, Germany
Bad Berka, Thüringen, Germany
Cusco, , Peru
Santiago De Compostela, A Coruña, Spain
Incheon, Incheon Gwang'yeogsi, Korea, Republic Of
Rio Cuarto, , Argentina
Mendoza, Provincia De Mendoza, Argentina
San Miguel De Tucumán, , Argentina
San Miguel De Tucumán, , Argentina
Santiago, , Chile
Santiago, , Chile
Marseille, , France
Löwenstein, , Germany
Bad Berka, , Germany
Monterrey, , Mexico
Monterrey, , Mexico
Rosario, Provincia De Santa Fe, Argentina
Cairns, Queensland, Australia
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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