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

Phase 3

Completed

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

Inclusion Criteria

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.

Exclusion Criteria

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): Arizona Pulmonary Specialists, Ltd.
🇺🇸
Phoenix, Arizona, United States
University of Arizona
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Tucson, Arizona, United States
University of California, San Francisco-Fresno
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Fresno, California, United States
Cedars-Sinai Medical Center
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Los Angeles, California, United States
University of California-Davis Medical Group, Advanced Lung Disease/Transplant Program
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Sacramento, California, United States
David Geffen School of Medicine
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Torrance, California, United States
University of Colorado Hospital
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Aurora, Colorado, United States
University of Florida
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Gainesville, Florida, United States
University of Florida College of Medicine Jacksonville- Division of Pulmonary & Critical Medicine
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Jacksonville, Florida, United States
Cleveland Clinic Florida
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Weston, Florida, United States
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Arizona Pulmonary Specialists, Ltd.
🇺🇸Phoenix, Arizona, United States