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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02633293
Other study ID # RIN-PH-202
Secondary ID
Status Terminated
Phase Phase 2/Phase 3
First received
Last updated
Start date September 15, 2016
Est. completion date August 1, 2021

Study information

Verified date November 2022
Source United Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Terminated
Enrollment 243
Est. completion date August 1, 2021
Est. primary completion date August 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Subject voluntarily gives informed consent to participate in the study. 2. 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. 3. 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. 4. Males must use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug. Exclusion Criteria: 1. The subject is pregnant or lactating. 2. The subject was prematurely discontinued from study RIN-PH-201. 3. 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


Intervention

Drug:
Inhaled Treprostinil
Inhaled treprostinil up to 15 breaths (90 mcg) four times daily

Locations

Country Name City State
Puerto Rico Alliance Cardio Pulmonary Research Group, Inc. Guaynabo
United States Albany Medical College Albany New York
United States The University of New Mexico Albuquerque New Mexico
United States AnMed Health Pulmonary and Sleep Medicine Anderson South Carolina
United States The Emory Clinic Atlanta Georgia
United States University of Colorado Hospital - Cardiac and Vascular Center Aurora Colorado
United States Piedmont - Georgia Lung Associates Austell Georgia
United States Johns Hopkins University Baltimore Maryland
United States University of Maryland Medical Center Baltimore Maryland
United States Cedars-Sinai Medical Center Beverly Hills California
United States University of Alabama at Birmingham Birmingham Alabama
United States Brigham and Women's Hospital Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Tufts Medical Center Boston Massachusetts
United States New York Methodist Hospital Brooklyn New York
United States Florida Lung, Asthma & Sleep Specialists, P.A. Celebration Florida
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States Northwestern University Chicago Illinois
United States Rush University Medical Center Chicago Illinois
United States University of Chicago Medical Center Chicago Illinois
United States University of Illinois at Chicago Hospital Chicago Illinois
United States The Carl and Edyth Lindner Research Center at The Christ Hospital Cincinnati Ohio
United States University of Cincinnati Health Cincinnati Ohio
United States St. Francis Sleep, Allergy and Lung Institute Clearwater Florida
United States Cleveland Clinic Cleveland Ohio
United States University Hospitals Cleveland Medical Center Cleveland Ohio
United States University of Vermont, Vermont Lung Center Colchester Vermont
United States The Ohio State University Medical Center Columbus Ohio
United States Baylor University Medical Center at Dallas Dallas Texas
United States UT Southwestern Medical Center Dallas Texas
United States National Jewish Health Denver Colorado
United States Duke University Medical Center Durham North Carolina
United States Texas Tech University Health Sciences Center El Paso Texas
United States Inova Fairfax Hospital Fairfax Virginia
United States University of California, San Francisco-Fresno Fresno California
United States University of Florida Clinical Research Center Gainesville Florida
United States Spectrum Health Medical Center Grand Rapids Michigan
United States Houston Methodist Houston Texas
United States Michael E. DeBakey VA Medical Center Houston Texas
United States The University of Texas Health Science Center at Houston Houston Texas
United States Community Heart and Vascular Hospital Indianapolis Indiana
United States Indiana University Hospital Indianapolis Indiana
United States St. Vincent Medical Group, Inc. Indianapolis Indiana
United States University of Iowa Hospitals & Clinics Iowa City Iowa
United States University of Mississippi Medical Center Jackson Mississippi
United States Mayo Clinic Jacksonville Jacksonville Florida
United States St. Vincent's Lung, Sleep, and Critical Care Specialists Jacksonville Florida
United States University of Florida College of Medicine, Jacksonville Jacksonville Florida
United States Saint Luke's Hospital of Kansas City Kansas City Missouri
United States University of Kansas Medical Center Kansas City Kansas
United States Statcare Pulmonary Consultants Knoxville Tennessee
United States University of California San Diego La Jolla California
United States VA Long Beach Healthcare System Long Beach California
United States Department of Veterans Affairs Greater Los Angeles Healthcare System Los Angeles California
United States University of Southern California Los Angeles California
United States University of Louisville Physicians Outpatient Center Louisville Kentucky
United States University of Wisconsin School of Medicine and Public Health Madison Wisconsin
United States Wellstar Medical Group Marietta Georgia
United States Loyola University Medical Center Maywood Illinois
United States University of Miami Miami Florida
United States Aurora St. Luke's Medical Center Milwaukee Wisconsin
United States Medical College of Wisconsin/Froedtert Hospital Milwaukee Wisconsin
United States University of Minnesota Minneapolis Minnesota
United States IMC-Diagnostic & Medical Clinic Mobile Alabama
United States Northwell Health New Hyde Park New York
United States Louisiana State University Health Sciences Center New Orleans New Orleans Louisiana
United States NYU Langone Medical Center New York New York
United States The Mount Sinai Hospital New York New York
United States Weill Cornell Medical Center New York New York
United States Sentara Cardiovascular Research Institute Norfolk Virginia
United States Integris Baptist Medical Center Oklahoma City Oklahoma
United States Florida Hospital Orlando Florida
United States Hospital of University of Pennsylvania Philadelphia Pennsylvania
United States Arizona Pulmonary Specialists, Ltd. Phoenix Arizona
United States Pinehurst Medical Clinic, Inc. Pinehurst North Carolina
United States Allegheny General Hospital Pittsburgh Pennsylvania
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States Pulmonary Associates of Richmond Richmond Virginia
United States Pacific Pulmonary Medical Group Riverside California
United States Mayo Clinic Rochester Minnesota
United States University of California Davis Medical Center Sacramento California
United States Washington University Hospital Saint Louis Missouri
United States The University of Texas Health Science Center at San Antonio San Antonio Texas
United States Kaiser Permanente San Francisco California
United States University of Washington Medical Center Seattle Washington
United States Maine Medical Center South Portland Maine
United States University of South Florida Tampa Florida
United States University of Arizona Tucson Arizona
United States Georgetown University Hospital Washington District of Columbia
United States MedStar Heart & Vascular Institute Washington District of Columbia
United States Cleveland Clinic Florida Weston Florida

Sponsors (1)

Lead Sponsor Collaborator
United Therapeutics

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Peak 6-Minute Walk Distance (6MWD) From Baseline 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. 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)
Secondary Change in Plasma Concentration of N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) From Baseline 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). 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)
Secondary Change in Percent Predicted Forced Vital Capacity (FVC) From Baseline 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. Baseline and Weeks 12, 48, and 108
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