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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
471
UT-15C extended release oral tablet three times daily
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.
Time frame: 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
Change in 6-Minute Walk Distance From Baseline
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.
Time frame: Baseline to Week 48
Change in Borg Dyspnea Score From 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).
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Arizona Pulmonary Specialists, Ltd.
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
University of California, San Francisco-Fresno
Fresno, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California-Davis Medical Group, Advanced Lung Disease/Transplant Program
Sacramento, California, United States
David Geffen School of Medicine
Torrance, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
University of Florida
Gainesville, Florida, United States
University of Florida College of Medicine Jacksonville- Division of Pulmonary & Critical Medicine
Jacksonville, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
...and 143 more locations
Time frame: Baseline to Week 48
Change From Baseline to Week 48 in WHO Functional Class
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.
Time frame: Baseline to Week 48
Change in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) From 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)
Time frame: Baseline to Week 48