An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Drug: UT-15C (treprostinil diolamine)
- Registration Number
- NCT01560637
- Lead Sponsor
- United Therapeutics
- Brief Summary
This study is an international, multi-center, open-label study designed to provide oral treprostinil (UT-15C) to eligible subjects with pulmonary arterial hypertension who have completed the TDE-PH-310 study. The purpose of this study is to assess the long-term safety of UT-15C and to assess the effects of long-term treatment with UT-15C on exercise capacity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 471
- Participated in United Therapeutics Study TDE-PH-310
- All women of childbearing potential (WOCBP) must have practiced true abstinence from intercourse when it was in line with their preferred and usual lifestyle or used 2 different forms of highly effective contraception for the duration of the study and for at least 30 days after discontinuing study medication.
- Males who participated in the study must have used a condom during the length of the study and for at least 48 hours after their last dose of study medication.
- The subject was pregnant or lactating.
- The subject had received infused or inhaled prostacyclin therapy for 29 days or more.
- The subject was prematurely discontinued from TDE-PH-310 for reasons other than a clinical worsening event.
- The subject developed a concurrent illness or condition during the conduct of TDE-PH-310 which, in the opinion of the Investigator, would represent a risk to their overall health if they enrolled in this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description UT-15C UT-15C (treprostinil diolamine) Open label access
- Primary Outcome Measures
Name Time Method Number of Adverse Events Participants will be followed every 12 weeks, at minimum, until they discontinue the study or the study is discontinued by the sponsor or for a period up to 2.5 years All subjects who received oral treprostinil in TDE-PH-311 were included in the Safety population. All AEs were captured from the time the ICF was signed. All AEs were followed until resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for up to 30 days if the AE extended beyond the final visit. All SAEs were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final visit. The overall summary of AEs includes the number of subjects with any AE, the number of subjects with any study drug-related AEs, the number of subjects with AEs leading to study drug withdrawal, the number of subjects with any serious AEs, the number of subjects with any severe AEs, and the number of subjects with any study drug-related severe/serious AEs. AEs were coded using the Medical Dictionary for Regulatory Activities.
- Secondary Outcome Measures
Name Time Method Change in Borg Dyspnea Score From Baseline to Week 48 Baseline to Week 48 Change in Borg Dyspnea Score from at Week 48 is provided for the Safety Population (all subjects who received oral treprostinil in TDE-PH-311).
The Borg Dyspnea Scale is a 0 to 10 rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise and was administered during six-minute walk testing (6MWT), one of the most common and frequently used measures to assess disease severity in PAH. The numbers on the scale are as follows: 0 (no shortness of breath \[SOB\]), 0.5 (very very slight SOB), 1 (very slight SOB), 3 (moderate SOB), 4 (somewhat severe SOB), 5 (severe SOB), 7 (very severe SOB), 9 (very very severe SOB), 10 (maximal SOB).Change in 6-Minute Walk Distance From Baseline Baseline to Week 48 A summary of change from Baseline in 6MWD at Week 48 for the Safety Population is provided. The Safety Population is all subjects who received oral treprostinil in TDE-PH-311.
Change From Baseline to Week 48 in WHO Functional Class Baseline to Week 48 Change from Baseline at Week 48 in WHO FC in the Safety Population (all subjects who received oral treprostinil in TDE-PH-311).
The World Health Organization functional classification (WHO-FC) is a clinician-rated assessment used widely to assess PAH severity and functioning.
Class I (least severe): Patients are without limitation of physical activity.
Class II: Patients are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope.
Class III: Marked limitation of physical activity. They are comfortable at rest.
Class IV (most severe): Inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure.Change in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) From Baseline to Week 48 Baseline to Week 48 Change in N-terminal pro-brain natriuretic peptide from Baseline at Week 48 for the Safety Population (any subject who received oral treprostinil in TDE-PH-311)
Trial Locations
- Locations (153)
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Indiana University Hospital
🇺🇸Carmel, Indiana, United States
Asheville Cardiology Associates
🇺🇸Asheville, North Carolina, United States
Perelman Center for Advanced Medicine, University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center - Presbyterian Cardiovascular Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
Macquarie University
🇦🇺Sydney, New South Wales, Australia
Universitätsmedizin Greifswald
🇩🇪Greifswald, Mecklenburg-vorpommern, Germany
Royal Free Hospital
🇬🇧London, England, United Kingdom
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
Augusta University
🇺🇸Augusta, Georgia, United States
Hospital Italiano de Buenos Aires
🇦🇷Ciudad Autónoma de Buenos Aires, Distrito Federal, Argentina
Sanatorio de la Trinidad Mitre
🇦🇷Buenos Aires, Argentina
Hospital Italiano Garibaldi
🇦🇷Rosario, Santa Fe, Argentina
Sanatorio San José
🇦🇷Caba, Buenos Aires, Argentina
Hospital Dr. José María Cullen
🇦🇷Santa Fe, Argentina
CARE Hospital
🇮🇳Hyderabad, Andhra Pradesh, India
Care Institute Medical Sciences
🇮🇳Ahmedabad, Gujarat, India
David Geffen School of Medicine
🇺🇸Torrance, California, United States
University of Florida College of Medicine Jacksonville- Division of Pulmonary & Critical Medicine
🇺🇸Jacksonville, Florida, United States
Escola Paulista de Medicina, Universidade Federal de São Paulo
🇧🇷São Paulo, SAO Paulo, Brazil
Hospital Alemão Oswaldo Cruz
🇧🇷São Paulo, Brazil
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Vancouver Coastal Health
🇨🇦Vancouver, British Columbia, Canada
West China Hospital
🇨🇳Chengdu, Sichuan, China
Chinese PLA General Hospital
🇨🇳Beijing, China
Beijing Shijitan Hospital
🇨🇳Beijing, China
KEM Hospital
🇮🇳Mumbai, Maharashtra, India
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Zhongshan Hospital Fudan University
🇨🇳Shanghai, Shanghai, China
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Indraprastha Apollo Hospital
🇮🇳New Delhi, Delhi, India
Complexo Hospitalar Santa Casa de Porto Alegre
🇧🇷Porto Alegre, RIO Grande DO SUL, Brazil
Universitätsklinikum des Saarlandes
🇩🇪Homburg, Saarland, Germany
Hospital Madre Teresa
🇧🇷Belo Horizonte, Minas Gerais, Brazil
G. Kuppuswamy Naidu Memorial Hospital
🇮🇳Coimbatore, Tamil NADU, India
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
National Cheng Kung University Hospital
🇨🇳Tainan, Tainan CITY, Taiwan
Arizona Pulmonary Specialists, Ltd.
🇺🇸Phoenix, Arizona, United States
University of California, San Francisco-Fresno
🇺🇸Fresno, California, United States
Cleveland Clinic Florida
🇺🇸Weston, Florida, United States
Piedmont - Georgia Lung Associates
🇺🇸Austell, Georgia, United States
HeartCare Midwest
🇺🇸Peoria, Illinois, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Beaumont Health
🇺🇸Troy, Michigan, United States
University of Rochester
🇺🇸Rochester, New York, United States
University Hospital
🇺🇸Cleveland, Ohio, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Sentara Cardiovascular Research Institute
🇺🇸Norfolk, Virginia, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Nepean Hospital
🇦🇺Kingswood, New South Wales, Australia
Saint Vincents Hospital
🇦🇺Sydney, New South Wales, Australia
Prince Charles Hospital
🇦🇺Chermside, Queensland, Australia
Royal Hobart Hospital
🇦🇺Hobart, Tasmania, Australia
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Krankenhaus Elisabethinen Linz
🇦🇹Linz, Upper Austria, Austria
Hospital das Clinicas da Universidade Federal de Goias
🇧🇷Goiania, Goias, Brazil
Medizinische Universität Wien
🇦🇹Wien, Austria
Hospital das Clínicas da Universidade Federal de Minas Gerais
🇧🇷Belo Horizonte, Minas Gerais, Brazil
Centro de Investigaciones TASOL
🇨🇱Santiago, Region Metropolitana, Chile
Hospital das Clínicas da Faculdade de Medicina de Botucatu- UNESP
🇧🇷Botucatu, SAO Paulo, Brazil
Lawson Health Research Institute
🇨🇦London, Ontario, Canada
Hospital da Clínicas da Faculdade de Medicina da Universidade de São Paulo
🇧🇷São Paulo, SAO Paulo, Brazil
Respiratory Research Foundation
🇨🇦Calgary, Alberta, Canada
Clínica Tabancura
🇨🇱Vitacura, Santiago, Chile
Beijing Chao-Yang Hospital
🇨🇳Beijing, Beijing, China
Guangdong General Hospital
🇨🇳Guangzhou, Guangdong, China
Wuhan Asia Heart Hospital
🇨🇳Wuhan, Hubei, China
Xiangya Hospital
🇨🇳Changsha, Hunan, China
The First Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanchang Medical University
🇨🇳Nanchang, Jiangxi, China
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Peking Union Medical College Hospital
🇨🇳Beijing, China
The Affiliated Hospital of Qingdao University
🇨🇳Qingdao, China
Shanghai Pulmonary Hospital of Tongji University
🇨🇳Shanghai, China
Aarhus Universitetshospital, Skejby
🇩🇰Aarhus, Denmark
Renji Hospital of Shanghai Jiaotong University
🇨🇳Shanghai, China
Hopital Brabois
🇫🇷Vandoeuvre-Les-Nancy, Limousin, Lorraine, France
Shenyang General Hospital of Shenyang Military Command
🇨🇳Shenyang, China
Hopital Haut-Leveque, CHU Bordeaux
🇫🇷Pessac, Aquitaine, France
Rigshospitalet-Copenhagen University Hospital
🇩🇰Copenhagen, Denmark
Hopital Jean Minjoz Centre Hospitalier Universitaire Besancon
🇫🇷Besancon, Franche-comte, France
CHU de Montpellier
🇫🇷Montpellier cedex 5, Languedoc-roussillon, France
Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez
🇫🇷Lille, NORD Pas-de-calais, France
Centre Hospitalier Universitaire Hopital Nord
🇫🇷Marseille, Provence Alpes COTE D'azur, France
Thoraxklinik am Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Baden-wuerttemberg, Germany
Ludwig-Maximilians-Universitat Munchen
🇩🇪Munchen, Bayern, Germany
Universitätsklinikum Regensburg
🇩🇪Regensburg, Bayern, Germany
Missionsarztliche Klinik Wurzburg gGmbH
🇩🇪Wurzburg, Bayern, Germany
Universitätsmedizin der Johannes Gutenberg Universität
🇩🇪Mainz, Rheinland-pfalz, Germany
Herzzentrum Duisburg
🇩🇪Duisburg, Nordrhein-westfalen, Germany
Universitätsklinikum Köln
🇩🇪Köln, Nordrhein-westfalen, Germany
Bergmannsheil Berufsgenossenschaftliche Universitätsklinik GmbH
🇩🇪Bochum, Nordrhein-westfalen, Germany
Technische Universität Dresden
🇩🇪Dresden, Sachsen, Germany
Universitätskrankenhaus Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Universitätsklinikum Leipzig
🇩🇪Leipzig, Sachsen, Germany
University General Hospital of Attikon
🇬🇷Athens, Attica, Greece
General Hospital of Thessaloniki, "G.Papanikolaou"
🇬🇷Thessaloniki, Macedoni, Greece
Sir Ganga Ram Hospital
🇮🇳New Delhi, Delhi, India
Mediciti Hospital
🇮🇳Hyderabad, Andhra Pradesh, India
Narayana Institute of Cardiac Sciences
🇮🇳Bangalore, Karnataka, India
Medanta - The Medicity
🇮🇳Gurgaon, Haryana, India
Apollo Hospitals International, Ltd.
🇮🇳Gandhinagar, Gujarat, India
Apollo Hospital
🇮🇳Chennai, Tamil NADU, India
King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College
🇮🇳Mumbai, Maharashtra, India
The Chaim Sheba Medical Center at Tel Hashomer
🇮🇱Tel Hashomer, Tel Aviv, Israel
Hadassah Medical Center
🇮🇱Jerusalem, Israel
Rabin Medical Center
🇮🇱Petach Tikvah, Petah Tiqwa, Israel
Rambam Health Corp.
🇮🇱Haifa, Israel
Carmel Medical Center
🇮🇱Haifa, Israel
Fondazione IRCCS Policlinico S. Matteo
🇮🇹Pavia, Italy
Azienda Ospedaliera Universitaria
🇮🇹Napoli, Italy
Istituto Mediterraneo Trapianti e Terapia Alta Specializzazione (ISMETT)
🇮🇹Palermo, Italy
Azienda Policlinico Umberto I di Roma
🇮🇹Roma, Italy
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Unidad de Investigacion Clinica en Medicina S.C.
🇲🇽Monterrey, Nuevo LEON, Mexico
Instituto Nacional de Cardiologia Ignacio Chavez
🇲🇽Tlalpan, Distrito Federal, Mexico
Universitair Medisch Centrum Sint Radboud
🇳🇱Nijmegen, Gelderland, Netherlands
Vrije Universiteit Medisch Centrum
🇳🇱Amsterdam, Noord-holland, Netherlands
Uniwersytecki Szpital Kliniczny w Bialymstoku
🇵🇱Bialystok, Poland
Krakowski Szpital Specjalistyczny im. Jana Pawla II
🇵🇱Malogoskie, Poland
Europejskie Centrum Zdrowia Otwock, Szpital im. Fryderyka Chopina
🇵🇱Otwock, Poland
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K. Marcinkowskiego w Poznaniu
🇵🇱Krakow, Poland
National University Hospital
🇸🇬Singapore, Singapore
National Heart Centre Singapore
🇸🇬Singapore, Singapore
Sahlgrenska University Hospital
🇸🇪Göteborg, Vastra Gotaland, Sweden
Karolinska University Hospital Solna
🇸🇪Stockholm, Sweden
Papworth Hospital
🇬🇧Papworth Everard, Cambridgshire, United Kingdom
Veterans General Hospital-Kaohsiung
🇨🇳Kaohsiung, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Freeman Hospital
🇬🇧Newcastle upon Tyne, England, United Kingdom
Royal Hallamshire Hospital
🇬🇧Sheffield, England, United Kingdom
University of Florida
🇺🇸Gainesville, Florida, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
University of California-Davis Medical Group, Advanced Lung Disease/Transplant Program
🇺🇸Sacramento, California, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
Kentuckiana Pulmonary Associates
🇺🇸Louisville, Kentucky, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Legacy Research Institute
🇺🇸Portland, Oregon, United States
Aurora Saint Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Ruby Hall Clinic
🇮🇳Pune, Maharashtra, India
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States