An Open Label Extension Study to Evaluate Inhaled Treprostinil in Adult PH With ILD Including CPFE
Status: | Enrolling by invitation |
---|---|
Conditions: | Lung Cancer, Chronic Obstructive Pulmonary Disease, High Blood Pressure (Hypertension), High Blood Pressure (Hypertension), Pulmonary, Pulmonary, Pulmonary |
Therapuetic Areas: | Cardiology / Vascular Diseases, Oncology, Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/3/2019 |
Start Date: | September 2016 |
End Date: | November 2022 |
An Open-Label Extension Study of Inhaled Treprostinil in Subjects With Pulmonary Hypertension Due to Parenchymal Lung Disease
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).
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).
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.
We found this trial at
113
sites
3800 Reservoir Rd NW
Washington, District of Columbia 20007
Washington, District of Columbia 20007
(202) 444-2000
Georgetown University Hospital MedStar Georgetown University Hospital is a not-for-profit, acute-care teaching and research hospital...
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Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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7000 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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University of Southern California The University of Southern California is one of the world’s leading...
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750 Highland Avenue
Madison, Wisconsin 53792
Madison, Wisconsin 53792
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University of Miami A private research university with more than 15,000 students from around the...
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Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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4502 Medical Drive
San Antonio, Texas 78284
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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University of South Florida The University of South Florida is a high-impact, global research university...
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Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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New York Methodist Hospital A voluntary, acute-care teaching hospital, New York Methodist Hospital's mission is...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Michael E. Debakey VA Medical Center The Michael E. DeBakey VA Medical Center serves as...
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University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Saint Luke's Hospital, Kansas City Saint Luke's Hospital is a not-for-profit tertiary referral center committed...
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The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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11301 Wilshire Boulevard
Los Angeles, California 90073
Los Angeles, California 90073
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Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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Aurora St. Luke's Medical Center At Aurora St. Luke's Medical Center, you'll find remarkable treatment...
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Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Florida Hospital Florida Hospital is one of the country
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Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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9427 Southwest Barnes Road
Portland, Oregon 97225
Portland, Oregon 97225
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