An Open Label Extension Study to Evaluate Inhaled Treprostinil in Adult PH With ILD Including CPFE
- Conditions
- Pulmonary HypertensionInterstitial Lung DiseaseCombined Pulmonary Fibrosis and Emphysema
- Interventions
- Registration Number
- NCT02633293
- Lead Sponsor
- United Therapeutics
- Brief Summary
This is a multicenter, open-label trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE). The study will include about 266 patients who completed all required assessments in the RIN-PH-201 study at approximately 100 clinical trial centers. The study will continue Your participation in this study is voluntary and will last until you discontinue from the study or the study ends. The study will continue until each subject reaches the Week 108 visit or until inhaled treprostinil become commercially available for patients with PH associated with ILD including CPFE (whichever is sooner).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 243
-
Subject voluntarily gives informed consent to participate in the study.
-
The subject participated in study RIN-PH-201, remained on study drug, was compliant with RIN-PH-201 study procedures or was enrolled in study RIN-PH-201 at the time that the study was discontinued by the sponsor.
-
Females of reproductive potential must be non-pregnant (as confirmed by a urine pregnancy test at Baseline) and non-lactating, and will:
- Either abstain from intercourse (when it is in line with their preferred and usual lifestyle), or
- Use two medically acceptable, highly-effective forms of contraception for the duration of study, and at least 30 days after discontinuing study drug.
-
Males must use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.
- The subject is pregnant or lactating.
- The subject was prematurely discontinued from study RIN-PH-201.
- The subject developed a concurrent illness or condition during the conduct of RIN-PH-201 which, in the opinion of the Investigator, would represent a risk to overall health if they enrolled in this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Inhaled Treprostinil Inhaled Treprostinil Open-label access
- Primary Outcome Measures
Name Time Method Change in Peak 6-Minute Walk Distance (6MWD) From Baseline Baseline through Week 124 in RIN-PH-202 (Combined data from parent study RIN-PH-201 [NCT02630316] and this open-label extension study RIN-PH-202) The intent of the 6MWD test is to evaluate exercise capacity associated with carrying out activities of daily living. Change in 6MWD from Baseline correlates with the current clinical standard for assessing patient functional status in the treatment of PH and is considered an objective measure of patient functional status. Subjects will be instructed to walk down a corridor at a comfortable speed as far as they can manage for 6 minutes. Distance \<500 meters suggests considerable exercise limitation; Distance 500-800 meters suggests moderate limitation; Distance \>800 meters (with no rests) suggests mild or no limitation. Peak exposure 6MWD will occur by conducting 6MWT within 10 to 60 minutes after the most recent dose of study drug dose.
- Secondary Outcome Measures
Name Time Method Change in Plasma Concentration of N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) From Baseline Baseline through Week 124 in RIN-PH-202 (Combined data from parent study RIN-PH-201 [NCT02630316] and this open-label extension study RIN-PH-202) The N-terminal pro-BNP (NT-proBNP) serum concentration is a useful biomarker associated with changes in right heart morphology and function. NT-proBNP serum concentration will be assessed to compare the severity of heart failure at Baseline and each visit through Week 124. Blood for NT-proBNP assessment must be drawn prior to conducting the 6-minute walk test (6MWT).
Change in Percent Predicted Forced Vital Capacity (FVC) From Baseline Baseline and Weeks 12, 48, and 108 Change in pulmonary function following inhaled treprostinil therapy will be measured by Forced Vital Capacity (FVC), calculated from a Pulmonary Function Test (PFT) performed at Baseline and Weeks 12, 48, and 108.
Trial Locations
- Locations (92)
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
University of Illinois at Chicago Hospital
🇺🇸Chicago, Illinois, United States
Indiana University Hospital
🇺🇸Indianapolis, Indiana, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Houston Methodist
🇺🇸Houston, Texas, United States
Michael E. DeBakey VA Medical Center
🇺🇸Houston, Texas, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
University of Cincinnati Health
🇺🇸Cincinnati, Ohio, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
The Carl and Edyth Lindner Research Center at The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
The University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Florida Lung, Asthma & Sleep Specialists, P.A.
🇺🇸Celebration, Florida, United States
IMC-Diagnostic & Medical Clinic
🇺🇸Mobile, Alabama, United States
University of California, San Francisco-Fresno
🇺🇸Fresno, California, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Department of Veterans Affairs Greater Los Angeles Healthcare System
🇺🇸Los Angeles, California, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
AnMed Health Pulmonary and Sleep Medicine
🇺🇸Anderson, South Carolina, United States
Baylor University Medical Center at Dallas
🇺🇸Dallas, Texas, United States
Arizona Pulmonary Specialists, Ltd.
🇺🇸Phoenix, Arizona, United States
Kaiser Permanente
🇺🇸San Francisco, California, United States
University of California San Diego
🇺🇸La Jolla, California, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
NYU Langone Medical Center
🇺🇸New York, New York, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of Colorado Hospital - Cardiac and Vascular Center
🇺🇸Aurora, Colorado, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Aurora St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Medical College of Wisconsin/Froedtert Hospital
🇺🇸Milwaukee, Wisconsin, United States
Cedars-Sinai Medical Center
🇺🇸Beverly Hills, California, United States
Pacific Pulmonary Medical Group
🇺🇸Riverside, California, United States
Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
Mayo Clinic Jacksonville
🇺🇸Jacksonville, Florida, United States
St. Vincent's Lung, Sleep, and Critical Care Specialists
🇺🇸Jacksonville, Florida, United States
University of Miami
🇺🇸Miami, Florida, United States
The Emory Clinic
🇺🇸Atlanta, Georgia, United States
Wellstar Medical Group
🇺🇸Marietta, Georgia, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Community Heart and Vascular Hospital
🇺🇸Indianapolis, Indiana, United States
St. Vincent Medical Group, Inc.
🇺🇸Indianapolis, Indiana, United States
University of Iowa Hospitals & Clinics
🇺🇸Iowa City, Iowa, United States
Maine Medical Center
🇺🇸South Portland, Maine, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Spectrum Health Medical Center
🇺🇸Grand Rapids, Michigan, United States
Washington University Hospital
🇺🇸Saint Louis, Missouri, United States
Albany Medical College
🇺🇸Albany, New York, United States
New York Methodist Hospital
🇺🇸Brooklyn, New York, United States
The University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
The Mount Sinai Hospital
🇺🇸New York, New York, United States
Northwell Health
🇺🇸New Hyde Park, New York, United States
Weill Cornell Medical Center
🇺🇸New York, New York, United States
Pinehurst Medical Clinic, Inc.
🇺🇸Pinehurst, North Carolina, United States
Integris Baptist Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Hospital of University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Texas Tech University Health Sciences Center
🇺🇸El Paso, Texas, United States
Inova Fairfax Hospital
🇺🇸Fairfax, Virginia, United States
Sentara Cardiovascular Research Institute
🇺🇸Norfolk, Virginia, United States
Alliance Cardio Pulmonary Research Group, Inc.
🇵🇷Guaynabo, Puerto Rico
MedStar Heart & Vascular Institute
🇺🇸Washington, District of Columbia, United States
VA Long Beach Healthcare System
🇺🇸Long Beach, California, United States
Piedmont - Georgia Lung Associates
🇺🇸Austell, Georgia, United States
Statcare Pulmonary Consultants
🇺🇸Knoxville, Tennessee, United States
St. Francis Sleep, Allergy and Lung Institute
🇺🇸Clearwater, Florida, United States
University of Florida College of Medicine, Jacksonville
🇺🇸Jacksonville, Florida, United States
Cleveland Clinic Florida
🇺🇸Weston, Florida, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
University of Vermont, Vermont Lung Center
🇺🇸Colchester, Vermont, United States
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
Florida Hospital
🇺🇸Orlando, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
University of Louisville Physicians Outpatient Center
🇺🇸Louisville, Kentucky, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Saint Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Florida Clinical Research Center
🇺🇸Gainesville, Florida, United States
Louisiana State University Health Sciences Center New Orleans
🇺🇸New Orleans, Louisiana, United States
Pulmonary Associates of Richmond
🇺🇸Richmond, Virginia, United States
University of Wisconsin School of Medicine and Public Health
🇺🇸Madison, Wisconsin, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States