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Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis

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.
 
ClinicalTrials.gov Identifier: NCT02603068
Recruitment Status : Withdrawn (Study design was inadequate and would not achieve study endpoints)
First Posted : November 11, 2015
Last Update Posted : February 9, 2016
Sponsor:
Information provided by (Responsible Party):
United Therapeutics

Brief Summary:
This multicenter, randomized, open-label study will assess the safety and efficacy of oral treprostinil in subjects diagnosed with pulmonary hypertension associated with pulmonary fibrosis.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Pulmonary Fibrosis Drug: Oral treprostinil Phase 2

Detailed Description:
This study will evaluate how oral treprostinil can affect pulmonary vascular resistance, as assessed by right heart catheterization, and exercise capacity, as assessed by the Six-Minute Walk Test. This is a 16-week study that will involve at least 10 clinical trial centers. The expected enrollment period is around 24 months and 52 subjects will be entered into the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Open Label Trial to Evaluate the Safety and Efficacy of Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis
Study Start Date : February 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Individual Maximum Tolerated Dose (iMTD)
Subjects are allowed to titrate oral treprostinil up to a maximum dose of 12 mg TID.
Drug: Oral treprostinil
Oral treprostinil will be administered as TID dosing for up to 16 Weeks.
Other Name: Orenitram

Experimental: Fixed Dose (FD)
Subjects are allowed to titrate oral treprostinil up to a maximum dose of 1 mg TID.
Drug: Oral treprostinil
Oral treprostinil will be administered as TID dosing for up to 16 Weeks.
Other Name: Orenitram




Primary Outcome Measures :
  1. Change in pulmonary vascular resistance (PVR) [ Time Frame: Baseline to Week 16 ]
    Change in PVR between iMTD and fixed dose groups


Secondary Outcome Measures :
  1. Change in Six-minute walk distance (6MWD) [ Time Frame: Baseline to Week 16 ]
    Change in 6MWD between iMTD and fixed dose groups

  2. Change in N-terminal pro-brain natriuretic peptide (NT-ProBNP) [ Time Frame: Baseline to Week 16 ]
    Change in NT-ProBNP between iMTD and fixed dose groups



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Voluntarily gives informed consent
  • Must meet criteria for lung transplant referral but is not required to be on an active lung transplant list
  • Stable and significant diffuse parenchymal lung disease with a diagnosis of interstitial lung disease
  • 6MWD greater than or equal to 75 meters
  • Right heart catheterization with a mean pulmonary arterial pressure >= 30 mgHg, pulmonary capillary wedge pressure <= 15 mmHg and pulmonary vascular resistance > 240 dynes
  • Echo-Doppler examination showing evidence of right ventricular dysfunction and normal left diastolic ventricular function
  • Either not receiving any PAH-approved oral therapy, or is receiving monotherapy (ERA, PDE-5I, or riociguat) for > 60 days and receiving a stable dose for > 30 days prior to enrollment
  • Able to communicate effectively with study personnel and will to be cooperative with protocol requirements

Exclusion Criteria:

  • History of repaired or unrepaired congenital heart disease
  • Received prostanoid therapy in the past 30 days, or has shown an intolerance or lack of efficacy to prostanoid therapy resulting in discontinuation or inability to titrate prostacyclins
  • Diagnosis of sarcoidosis
  • History of thromboembolic disease
  • Chronic renal insufficiency
  • Pregnancy or lactating
  • Currently receiving an investigational drug, has an investigational device in place, or has participated in an investigational drug or device study within 30 days prior to Screening

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): NCT02603068


Locations
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United States, Arizona
Banner University Medical Center Phoenix Advanced Lung Disease
Phoenix, Arizona, United States, 85006
United States, California
University of California, Los Angeles - Pulmonary Division
Los Angeles, California, United States, 90024
University of California - Davis Medical Group
Sacramento, California, United States, 95817
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
United States, Maryland
Johns Hopkins University
Baltiomore, Maryland, United States, 21205
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
CLC Pulmonary Hypertension Clinic Division of Pulmonary, Allergy and Critical Care Medicine UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
United Therapeutics
Investigators
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Principal Investigator: Rajan Saggar, MD University of California, Los Angeles - Pulmonary Division
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Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT02603068    
Other Study ID Numbers: TDE-PH-204
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Study is withdrawn. There is no data to share.
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Pulmonary Fibrosis
Hypertension
Fibrosis
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Treprostinil
Antihypertensive Agents