An Open Label Extension Study to Evaluate Inhaled Treprostinil in Adult PH With ILD Including CPFE

NCT02633293 | Terminated Phase 2 Results DMC

• 1 other identifier: RIN-PH-202
• Study Type: interventional
• Target: 243
• Locations: 2 countries
• Sites: 92

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).

Conditions

Pulmonary Hypertension; Interstitial Lung Disease; Combined Pulmonary Fibrosis and Emphysema

Keywords

Treprostinil; PH; ILD; CPFE; 6 Minute Walk Test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

• Change in Percent Predicted Forced Vital Capacity (FVC) From Baseline

  Baseline and Weeks 12, 48, and 108

Study Arms (1)

Inhaled Treprostinil

EXPERIMENTAL

Open-label access

Drug: Inhaled Treprostinil

Interventions

Inhaled Treprostinil DRUG

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

Also known as: Tyvaso

Inhaled Treprostinil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• United Therapeutics: lead

Study Sites (92)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

IMC-Diagnostic & Medical Clinic

Mobile, Alabama, 36604, United States

Location

Arizona Pulmonary Specialists, Ltd.

Phoenix, Arizona, 85012, United States

Location

University of Arizona

Tucson, Arizona, 85724, United States

Location

Cedars-Sinai Medical Center

Beverly Hills, California, 90211, United States

Location

University of California, San Francisco-Fresno

Fresno, California, 93701, United States

Location

University of California San Diego

La Jolla, California, 92093, United States

Location

VA Long Beach Healthcare System

Long Beach, California, 90822, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Department of Veterans Affairs Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

Location

Pacific Pulmonary Medical Group

Riverside, California, 92505, United States

Location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Kaiser Permanente

San Francisco, California, 94115, United States

Location

University of Colorado Hospital - Cardiac and Vascular Center

Aurora, Colorado, 80045, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

MedStar Heart & Vascular Institute

Washington D.C., District of Columbia, 20010, United States

Location

Florida Lung, Asthma & Sleep Specialists, P.A.

Celebration, Florida, 34747, United States

Location

St. Francis Sleep, Allergy and Lung Institute

Clearwater, Florida, 33765, United States

Location

University of Florida Clinical Research Center

Gainesville, Florida, 32610, United States

Location

University of Florida College of Medicine, Jacksonville

Jacksonville, Florida, 32209, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

St. Vincent's Lung, Sleep, and Critical Care Specialists

Jacksonville, Florida, 33204, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Florida Hospital

Orlando, Florida, 32804, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

The Emory Clinic

Atlanta, Georgia, 30322, United States

Location

Piedmont - Georgia Lung Associates

Austell, Georgia, 30106, United States

Location

Wellstar Medical Group

Marietta, Georgia, 30060, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Illinois at Chicago Hospital

Chicago, Illinois, 60612, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

Community Heart and Vascular Hospital

Indianapolis, Indiana, 46250, United States

Location

St. Vincent Medical Group, Inc.

Indianapolis, Indiana, 46260, United States

Location

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Louisville Physicians Outpatient Center

Louisville, Kentucky, 40202, United States

Location

Louisiana State University Health Sciences Center New Orleans

New Orleans, Louisiana, 70112, United States

Location

Maine Medical Center

South Portland, Maine, 04106, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Spectrum Health Medical Center

Grand Rapids, Michigan, 49503, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Washington University Hospital

St Louis, Missouri, 63110, United States

Location

The University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Albany Medical College

Albany, New York, 12208, United States

Location

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Northwell Health

New Hyde Park, New York, 11040, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

The Mount Sinai Hospital

New York, New York, 10029, United States

Location

Weill Cornell Medical Center

New York, New York, 10065, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Pinehurst Medical Clinic, Inc.

Pinehurst, North Carolina, 28374, United States

Location

The Carl and Edyth Lindner Research Center at The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

University of Cincinnati Health

Cincinnati, Ohio, 45267, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, 43221, United States

Location

Integris Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

Location

Hospital of University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

AnMed Health Pulmonary and Sleep Medicine

Anderson, South Carolina, 29621, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Statcare Pulmonary Consultants

Knoxville, Tennessee, 37919, United States

Location

Baylor University Medical Center at Dallas

Dallas, Texas, 75246, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Texas Tech University Health Sciences Center

El Paso, Texas, 79905, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

University of Vermont, Vermont Lung Center

Colchester, Vermont, 05446, United States

Location

Inova Fairfax Hospital

Fairfax, Virginia, 22042, United States

Location

Sentara Cardiovascular Research Institute

Norfolk, Virginia, 23507, United States

Location

Pulmonary Associates of Richmond

Richmond, Virginia, 23229, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Medical College of Wisconsin/Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Alliance Cardio Pulmonary Research Group, Inc.

Guaynabo, 00968, Puerto Rico

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Lung Diseases, Interstitial; Emphysema

Interventions

treprostinil

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Global Medical Information
• Organization: United Therapeutics Corp.

clinicaltrials@unither.com

919-485-8350

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: December 17, 2015
• Study Start: September 15, 2016
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: December 2, 2022
• Results First Posted: December 2, 2022

Record last verified: 2022-11

Locations

US (91); PR (1)