An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension

NCT01560637 | Completed Phase 3 Results DMC

• 1 other identifier: TDE-PH-311
• Study Type: interventional
• Target: 471
• Locations: 22 countries
• Sites: 151

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.

Conditions

Pulmonary Arterial Hypertension

Keywords

PAH; PH; FREEDOM; 6 minute walk test; treprostinil; open label

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

  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.

  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

Secondary Outcomes (4)

• Change in 6-Minute Walk Distance From Baseline

  Baseline to Week 48

• Change in Borg Dyspnea Score From Baseline to Week 48

  Baseline to Week 48

• Change From Baseline to Week 48 in WHO Functional Class

  Baseline to Week 48

• Change in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) From Baseline to Week 48

  Baseline to Week 48

Study Arms (1)

UT-15C

EXPERIMENTAL

Open label access

Drug: UT-15C (treprostinil diolamine)

Interventions

UT-15C (treprostinil diolamine) DRUG

UT-15C extended release oral tablet three times daily

UT-15C

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• United Therapeutics: lead

Study Sites (153)

Arizona Pulmonary Specialists, Ltd.

Phoenix, Arizona, 85012, United States

Location

University of Arizona

Tucson, Arizona, 85724, United States

Location

University of California, San Francisco-Fresno

Fresno, California, 93701, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90211, United States

Location

University of California-Davis Medical Group, Advanced Lung Disease/Transplant Program

Sacramento, California, 95817, United States

Location

David Geffen School of Medicine

Torrance, California, 90502, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

University of Florida College of Medicine Jacksonville- Division of Pulmonary & Critical Medicine

Jacksonville, Florida, 32209, United States

Location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

Piedmont - Georgia Lung Associates

Austell, Georgia, 30106, United States

Location

HeartCare Midwest

Peoria, Illinois, 61614, United States

Location

Indiana University Hospital

Carmel, Indiana, 46032, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 55242, United States

Location

Kentuckiana Pulmonary Associates

Louisville, Kentucky, 40202, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Beaumont Health

Troy, Michigan, 48085, United States

Location

Nebraska Medical Center

Omaha, Nebraska, 68198-5990, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Asheville Cardiology Associates

Asheville, North Carolina, 28803, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

University Hospital

Cleveland, Ohio, 44106, United States

Location

Ohio State University

Columbus, Ohio, 43321, United States

Location

Oregon Health and Science University

Portland, Oregon, 97201-3098, United States

Location

Legacy Research Institute

Portland, Oregon, 97210, United States

Location

Perelman Center for Advanced Medicine, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center - Presbyterian Cardiovascular Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Sentara Cardiovascular Research Institute

Norfolk, Virginia, 23507, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Sanatorio San José

CABA, Buenos Aires, C1425DUH, Argentina

Location

Hospital Italiano de Buenos Aires

Buenos Aires, Distrito Federal, C1181ACH, Argentina

Location

Hospital Italiano Garibaldi

Rosario, Santa Fe Province, S2001OAD, Argentina

Location

Sanatorio de la Trinidad Mitre

Buenos Aires, Argentina

Location

Hospital Dr. José María Cullen

Santa Fe, S3000EOY, Argentina

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Nepean Hospital

Kingswood, New South Wales, 2751, Australia

Location

Saint Vincents Hospital

Sydney, New South Wales, 2010, Australia

Location

Macquarie University

Sydney, New South Wales, 2109, Australia

Location

Prince Charles Hospital

Chermside, Queensland, 4032, Australia

Location

Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

Krankenhaus Elisabethinen Linz

Linz, Upper Austria, 4020, Austria

Location

Medizinische Universität Wien

Vienna, 1090, Austria

Location

Hospital das Clinicas da Universidade Federal de Goias

Goiânia, Goiás, 74605-050, Brazil

Location

Hospital das Clínicas da Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Location

Hospital Madre Teresa

Belo Horizonte, Minas Gerais, 30380-090, Brazil

Location

Complexo Hospitalar Santa Casa de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

Hospital das Clínicas da Faculdade de Medicina de Botucatu- UNESP

Botucatu, São Paulo, 18618-970, Brazil

Location

Hospital da Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, 05403-000, Brazil

Location

Escola Paulista de Medicina, Universidade Federal de São Paulo

São Paulo, São Paulo, Brazil

Location

Hospital Alemão Oswaldo Cruz

São Paulo, 01323-020, Brazil

Location

Respiratory Research Foundation

Calgary, Alberta, T1Y 6J4, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Vancouver Coastal Health

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Lawson Health Research Institute

London, Ontario, N6A 5A5, Canada

Location

Centro de Investigaciones TASOL

Santiago, Santiago Metropolitan, 7500710, Chile

Location

Clínica Tabancura

Vitacura, Santiago Metropolitan, 7650018, Chile

Location

Beijing Chao-Yang Hospital

Beijing, Beijing Municipality, 100020, China

Location

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

Location

Wuhan Asia Heart Hospital

Wuhan, Hubei, 430022, China

Location

Xiangya Hospital

Changsha, Hunan, 410008, China

Location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

The Second Affiliated Hospital of Nanchang Medical University

Nanchang, Jiangxi, 330006, China

Location

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200120, China

Location

West China Hospital

Chengdu, Sichuan, 610047, China

Location

Peking Union Medical College Hospital

Beijing, 100005, China

Location

Beijing Shijitan Hospital

Beijing, 100038, China

Location

Chinese PLA General Hospital

Beijing, 100853, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, 26603, China

Location

Renji Hospital of Shanghai Jiaotong University

Shanghai, 200001, China

Location

Shanghai Pulmonary Hospital of Tongji University

Shanghai, 200433, China

Location

Shenyang General Hospital of Shenyang Military Command

Shenyang, 110015, China

Location

Aarhus Universitetshospital, Skejby

Aarhus, 8200, Denmark

Location

Rigshospitalet-Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

Hopital Haut-Leveque, CHU Bordeaux

Pessac, Aquitaine, 33064, France

Location

Hopital Jean Minjoz Centre Hospitalier Universitaire Besancon

Besançon, Franche-comte, 25030, France

Location

Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez

Lille, Hauts-de-France, 59037, France

Location

CHU de Montpellier

Montpellier, Languedoc-roussillon, 34295, France

Location

Hopital Brabois

Vandœuvre-lès-Nancy, Limousin, Lorraine, 54500, France

Location

Centre Hospitalier Universitaire Hopital Nord

Marseille, Provence-Alpes-Côte d'Azur Region, 13015, France

Location

Thoraxklinik am Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, 69126, Germany

Location

Ludwig-Maximilians-Universitat Munchen

München, Bavaria, 81377, Germany

Location

Universitätsklinikum Regensburg

Regensburg, Bavaria, 93053, Germany

Location

Missionsarztliche Klinik Wurzburg gGmbH

Würzburg, Bavaria, 97074, Germany

Location

Universitätsmedizin Greifswald

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

Location

Bergmannsheil Berufsgenossenschaftliche Universitätsklinik GmbH

Bochum, North Rhine-Westphalia, 44789, Germany

Location

Universitätsklinikum Köln

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Herzzentrum Duisburg

Duisburg, North Rhine-Westphalia, 47137, Germany

Location

Universitätsmedizin der Johannes Gutenberg Universität

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Universitätsklinikum des Saarlandes

Homburg, Saarland, 66424, Germany

Location

Technische Universität Dresden

Dresden, Saxony, 01307, Germany

Location

Universitätsklinikum Leipzig

Leipzig, Saxony, 04103, Germany

Location

Universitätskrankenhaus Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

University General Hospital of Attikon

Athens, Attica, 12462, Greece

Location

General Hospital of Thessaloniki, "G.Papanikolaou"

Thessaloniki, Macedoni, 57010, Greece

Location

CARE Hospital

Hyderabad, Andhra Pradesh, 500 001, India

Location

Mediciti Hospital

Hyderabad, Andhra Pradesh, 500 063, India

Location

Care Institute Medical Sciences

Ahmedabad, Gujarat, 38006, India

Location

Apollo Hospitals International, Ltd.

Gandhinagar, Gujarat, 382428, India

Location

Medanta - The Medicity

Gurgaon, Haryana, 122 001, India

Location

Narayana Institute of Cardiac Sciences

Bangalore, Karnataka, 560 099, India

Location

KEM Hospital

Mumbai, Maharashtra, 400012, India

Location

King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College

Mumbai, Maharashtra, 400012, India

Location

Ruby Hall Clinic

Pune, Maharashtra, 411 001, India

Location

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, 110060, India

Location

Indraprastha Apollo Hospital

New Delhi, National Capital Territory of Delhi, 110076, India

Location

Apollo Hospital

Chennai, Tamil Nadu, 600006, India

Location

G. Kuppuswamy Naidu Memorial Hospital

Coimbatore, Tamil Nadu, 641037, India

Location

Rabin Medical Center

Petach Tikvah, Petah Tiqwa, 49100, Israel

Location

The Chaim Sheba Medical Center at Tel Hashomer

Tel Litwinsky, Tel Aviv, 52621, Israel

Location

Rambam Health Corp.

Haifa, 31096, Israel

Location

Carmel Medical Center

Haifa, 34362, Israel

Location

Hadassah Medical Center

Jerusalem, 91120, Israel

Location

Azienda Ospedaliera Universitaria

Napoli, Italy

Location

Istituto Mediterraneo Trapianti e Terapia Alta Specializzazione (ISMETT)

Palermo, 90127, Italy

Location

Fondazione IRCCS Policlinico S. Matteo

Pavia, 27100, Italy

Location

Azienda Policlinico Umberto I di Roma

Roma, 00161, Italy

Location

Instituto Nacional de Cardiologia Ignacio Chavez

Tlalpan, Mexico City, 14080, Mexico

Location

Unidad de Investigacion Clinica en Medicina S.C.

Monterrey, Nuevo León, 64718, Mexico

Location

Universitair Medisch Centrum Sint Radboud

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

Vrije Universiteit Medisch Centrum

Amsterdam, North Holland, 1081 HV, Netherlands

Location

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, 15276, Poland

Location

Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K. Marcinkowskiego w Poznaniu

Krakow, 61848, Poland

Location

Krakowski Szpital Specjalistyczny im. Jana Pawla II

Małogoskie, 31202, Poland

Location

Europejskie Centrum Zdrowia Otwock, Szpital im. Fryderyka Chopina

Otwock, Poland

Location

National University Hospital

Singapore, 119228, Singapore

Location

National Heart Centre Singapore

Singapore, 168 752, Singapore

Location

Gachon University Gil Medical Center

Incheon, 405-760, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, 413 45, Sweden

Location

Karolinska University Hospital Solna

Stockholm, 171 76, Sweden

Location

National Cheng Kung University Hospital

Tainan, Tainan CITY, 70403, Taiwan

Location

Veterans General Hospital-Kaohsiung

Kaohsiung City, 81362, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Papworth Hospital

Papworth Everard, Cambridgshire, CB3 8RE, United Kingdom

Location

Royal Free Hospital

London, England, NW3 2QG, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, England, NE7 7DN, United Kingdom

Location

Royal Hallamshire Hospital

Sheffield, England, S10 2JF, United Kingdom

Location

Related Publications (1)

• Grunig E, Rahaghi F, Elwing J, Vizza CD, Pepke-Zaba J, Shen J, Yao H, Hage A, Rosenkranz S, Vonk M, Balasubramanian V, Yuanhua Y, Yu Z, Lordan J, Cadaret L, Grover R, Ousmanou A, Seaman S, Deng C, Broderick M, White RJ; FREEDOM-EV Investigators. Oral Treprostinil is Associated with Improved Survival in FREEDOM-EV and its Open-Label Extension. Adv Ther. 2024 Feb;41(2):618-637. doi: 10.1007/s12325-023-02711-x. Epub 2023 Dec 6.

  PMID: 38055186 DERIVED

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

treprostinil

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Global Medical Information
• Organization: United Therapeutics Corp.

clinicaltrials@unither.com

919-485-8350

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2012
• First Posted: March 22, 2012
• Study Start: September 11, 2013
• Primary Completion: August 12, 2021
• Study Completion: August 12, 2021
• Last Updated: June 2, 2022
• Results First Posted: June 2, 2022

Record last verified: 2022-05

Locations

CN (16); ME (2); IL (5); SG (2); FR (6); SE (2); TW (4); GB (4); AU (8); DE (13); CL (2); BR (8); CA (4); DK (2); NL (2); IT (4); KR (5); US (38); PL (4); GR (2); AR (5); IN (13)