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Trial record 1 of 2 for:    RIN-PH-202
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An Open Label Extension Study to Evaluate Inhaled Treprostinil in Adult PH With ILD Including CPFE

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02633293
First Posted: December 17, 2015
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
United Therapeutics
  Purpose
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).

Condition Intervention Phase
Pulmonary Hypertension Interstitial Lung Disease Combined Pulmonary Fibrosis and Emphysema Drug: Inhaled Treprostinil Phase 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Extension Study of Inhaled Treprostinil in Subjects With Pulmonary Hypertension Due to Parenchymal Lung Disease

Resource links provided by NLM:


Further study details as provided by United Therapeutics:

Primary Outcome Measures:
  • Change in Peak 6-Minute Walk Distance (6MWD) from Baseline to the Week 48 Visit [ Time Frame: Baseline and Week 48 ]
    The intent of the 6MWD test is to evaluate exercise capacity associated with carrying out activities of daily living. Change in 6MWD from Baseline to Week 48, 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 six 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:
  • Change in plasma concentration of N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) from Baseline to the Week 48 Visit [ Time Frame: Baseline and Week 48 ]
    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 Week 48. Blood for NT-proBNP assessment must be drawn prior to conducting the 6-minute walk test (6MWT).

  • Change in Forced Expiratory Volume (FEV1) in One Second from Baseline to Week 48 [ Time Frame: Baseline and Week 48 ]
    Change in pulmonary function following inhaled treprostinil therapy will be measured by Forced Expiratory Volume in One Second (FEV1), the maximal amount of air forcefully exhaled in 1 second, calculated from a Pulmonary Function Test (PFT) performed at Baseline and Week 48.

  • Change in Forced Vital Capacity (FVC) from Baseline to Week 48 [ Time Frame: Baseline and Week 48 ]
    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 Week 48.

  • Change in Total Lung Capacity (TLC) from Baseline to Week 48 [ Time Frame: Baseline and Week 48 ]
    Change in pulmonary function following inhaled treprostinil therapy will be measured by Total Lung Capacity (TLC), calculated from a Pulmonary Function Test (PFT) performed at Baseline and Week 48.

  • Change in Lung Diffusion Capacity (DLCO) from Baseline to Week 48 [ Time Frame: Baseline and Week 48 ]
    Change in pulmonary function following inhaled treprostinil therapy will be measured by Lung Diffusion Capacity (DLCO), calculated from a Pulmonary Function Test (PFT) performed at Baseline and Week 48.

  • Incidence of Adverse Events Among Participants through Week 108 [ Time Frame: Week 108 ]
    Adverse events among participants will be recorded throughout participation in the study. The incidence of adverse events among participants through Week 108 will be described by the number of participants analyzed and the percentage of those participants who experienced an adverse event until Week 108.


Estimated Enrollment: 266
Actual Study Start Date: September 2016
Estimated Study Completion Date: October 2020
Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Inhaled Treprostinil
Open-label access
Drug: Inhaled Treprostinil
Inhaled treprostinil (6 mcg/breath) administered four times daily
Other Name: Tyvaso

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02633293


  Show 94 Study Locations
Sponsors and Collaborators
United Therapeutics
  More Information

Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT02633293     History of Changes
Other Study ID Numbers: RIN-PH-202
First Submitted: December 11, 2015
First Posted: December 17, 2015
Last Update Posted: November 17, 2017
Last Verified: November 2017

Keywords provided by United Therapeutics:
Treprostinil
PH
ILD
CPFE
6 Minute Walk Test

Additional relevant MeSH terms:
Hypertension
Lung Diseases
Hypertension, Pulmonary
Pulmonary Fibrosis
Emphysema
Lung Diseases, Interstitial
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Pathologic Processes
Treprostinil
Antihypertensive Agents