Study Stopped
Terminated by Sponsor
Open-label Extension of Oral Treprostinil in Subjects With PH Associated With HFpEF
An Open-label Extension Study of Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) Associated With Heart Failure With Preserved Ejection Fraction (HFpEF) - A Long-term Follow-up to Study TDE-HF-301
1 other identifier
interventional
48
1 country
82
Brief Summary
This was an open-label study to evaluate the safety of continued therapy with oral treprostinil in subjects who completed Study TDE-HF-301. This study provided long-term, open-label data regarding the effect of continued long-term oral treprostinil therapy for the treatment of pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF). Subject visits occurred at Baseline, Weeks 6, 12, 18, 24, and every 12 weeks thereafter until either oral treprostinil was commercially available to treat PH associated with HFpEF or the study was discontinued by the Sponsor. The Sponsor terminated Studies TDE-HF-301 and TDE-HF-302 on 14 October 2019 due to slow enrollment. Safety data from the final subject in Study TDE-HF-302 were recorded on 02 March 2020. Due to the lower than expected number of subjects enrolled, the planned secondary efficacy-related endpoints were not analyzed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2018
82 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2017
CompletedFirst Posted
Study publicly available on registry
February 6, 2017
CompletedStudy Start
First participant enrolled
January 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 2, 2020
CompletedResults Posted
Study results publicly available
October 22, 2020
CompletedOctober 22, 2020
September 1, 2020
2.1 years
January 31, 2017
September 25, 2020
September 25, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Long-term Safety of Oral Treprostinil in Subjects With PH Associated With HFpEF for Subjects Who Completed Study TDE-HF-301
The primary objective of this study was to evaluate the long-term safety of oral treprostinil in subjects with PH associated with HFpEF for subjects who completed Study TDE-HF-301. The number of subjects with adverse events during the study is reported as the primary outcome measure, which was the only outcome measurement reported for this Sponsor-terminated study.
Baseline through study completion, up to approximately 25 months
Study Arms (1)
Oral treprostinil
EXPERIMENTALSustained-release tablets for TID administration
Interventions
Sustained-release oral tablets for TID administration
Eligibility Criteria
You may qualify if:
- \. The subject participated in Study TDE-HF-301, remained on study drug, was compliant with study procedures and assessments during Study TDE-HF-301, and completed through Week 24 of that study.
You may not qualify if:
- The subject was pregnant or lactating.
- The subject was prematurely discontinued from Study TDE-HF-301 for any reason.
- The subject developed a concurrent illness or condition during Study TDE-HF-301, which, in the opinion of the Investigator, represented a risk to the subject's overall health if they enrolled in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (82)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Banner University Medical Center Phoenix
Phoenix, Arizona, 85006, United States
University of Arizona
Tucson, Arizona, 85724, United States
VA Healthcare System of Greater Los Angeles
Los Angeles, California, 90073, United States
University of California Los Angeles Pulmonary Division
Los Angeles, California, 90095, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90211, United States
University of California - Davis Medical Center
Sacramento, California, 95817, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, 93105, United States
Aurora Denver Cardiology Associates
Aurora, Colorado, 80012, United States
University of Colorado Denver
Aurora, Colorado, 80045, United States
National Jewish Health
Denver, Colorado, 80206, United States
South Denver Cardiology
Littleton, Colorado, 80120, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Medical Faculty Associates, George Washington University
Washington D.C., District of Columbia, 20037, United States
Bay Area Cardiology Associates
Brandon, Florida, 33511, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224, United States
St. Vincent's Lung, Sleep, and Critical Care Specialists
Jacksonville, Florida, 33204, United States
Central Florida Pulmonary Group, P.A.
Orlando, Florida, 32803, United States
Florida Hospital
Orlando, Florida, 32806, United States
University of South Florida ; Tampa General Hospital
Tampa, Florida, 33606, United States
Cleveland Clinic of Florida
Weston, Florida, 33331, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Augusta University
Augusta, Georgia, 30912, United States
Piedmont Physicians Georgia Lung
Austell, Georgia, 30309, United States
WellStar Medical Group
Marietta, Georgia, 30060, United States
University of Illinois at Chicago Hospital
Chicago, Illinois, 60612, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453, United States
OSF HealthCare
Peoria, Illinois, 61614, United States
Indiana University Health Methodist Research Institute, INC
Indianapolis, Indiana, 46202, United States
Community Heart and Vascular Hospital
Indianapolis, Indiana, 46250, United States
Saint Vincent Hospital and Health Services
Indianapolis, Indiana, 46260, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 55242, United States
Iowa Heart Center
West Des Moines, Iowa, 50266, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
University of Kentucky Medical Center
Lexington, Kentucky, 40536, United States
Kentuckiana Pulmonary Associates
Louisville, Kentucky, 40202, United States
University of Louisville Physicians Outpatient Center
Louisville, Kentucky, 40202, United States
Chest Medicine Associates
South Portland, Maine, 04106, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
St. Elizabeth's Medical Center
Brighton, Massachusetts, 02135, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Spectrum Health Medical Group
Grand Rapids, Michigan, 49503, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
St. Luke's Hospital
Chesterfield, Missouri, 63017, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Barnabas Health Lung Center
Newark, New Jersey, 07112, United States
Albany Medical College
Albany, New York, 12208, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Pulmonary Health Physicians, PC
Syracuse, New York, 13066, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Asheville Cardiology Associates
Asheville, North Carolina, 28803, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Pinehurst Medical Clinic
Pinehurst, North Carolina, 28374, United States
The Lindner Research Center The Christ Hospital Health Network
Cincinnati, Ohio, 45219, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
University of Toldedo Medical Center
Toledo, Ohio, 43614, United States
The Oregon Clinic
Portland, Oregon, 97225, United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17601, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
AnMed Health Pulmonary and Sleep Medicine
Anderson, South Carolina, 29621, United States
VitaLink Research - Anderson
Anderson, South Carolina, 29621, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Stern Cardiovascular Foundation
Germantown, Tennessee, 38138, United States
Summit Medical Group
Knoxville, Tennessee, 37909, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-2650, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Houston Methodist Research Institute
Houston, Texas, 77030, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Texas Tech University Health Sciences Center
Lubbock, Texas, 79905, United States
Intermountain Medical Center
Murray, Utah, 84143, United States
Inova Heart and Vascular Institute
Falls Church, Virginia, 22042, United States
Sentara Cardiovascular Research Institute
Norfolk, Virginia, 23507, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Carilion Clinic
Roanoke, Virginia, 24014, United States
Providence Medical Research Center
Spokane, Washington, 99204, United States
West Virginia University Hospital
Morgantown, West Virginia, 26506, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Louis Holdstock
- Organization
- United Therapeutics
Study Officials
- PRINCIPAL INVESTIGATOR
Mardi Gomberg-Maitland, MD
George Washington University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- 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
January 31, 2017
First Posted
February 6, 2017
Study Start
January 30, 2018
Primary Completion
March 2, 2020
Study Completion
March 2, 2020
Last Updated
October 22, 2020
Results First Posted
October 22, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share