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Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis

Primary Purpose

Pulmonary Hypertension, Pulmonary Fibrosis

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oral treprostinil
Sponsored by
United Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Banner University Medical Center Phoenix Advanced Lung Disease
  • University of California, Los Angeles - Pulmonary Division
  • University of California - Davis Medical Group
  • Emory University Hospital
  • Johns Hopkins University
  • Oregon Health and Science University
  • CLC Pulmonary Hypertension Clinic Division of Pulmonary, Allergy and Critical Care Medicine UPMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Individual Maximum Tolerated Dose (iMTD)

Fixed Dose (FD)

Arm Description

Subjects are allowed to titrate oral treprostinil up to a maximum dose of 12 mg TID.

Subjects are allowed to titrate oral treprostinil up to a maximum dose of 1 mg TID.

Outcomes

Primary Outcome Measures

Change in pulmonary vascular resistance (PVR)
Change in PVR between iMTD and fixed dose groups

Secondary Outcome Measures

Change in Six-minute walk distance (6MWD)
Change in 6MWD between iMTD and fixed dose groups
Change in N-terminal pro-brain natriuretic peptide (NT-ProBNP)
Change in NT-ProBNP between iMTD and fixed dose groups

Full Information

First Posted
November 10, 2015
Last Updated
February 5, 2016
Sponsor
United Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT02603068
Brief Title
Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis
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 Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Study design was inadequate and would not achieve study endpoints
Study Start Date
February 2016 (undefined)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension, Pulmonary Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individual Maximum Tolerated Dose (iMTD)
Arm Type
Experimental
Arm Description
Subjects are allowed to titrate oral treprostinil up to a maximum dose of 12 mg TID.
Arm Title
Fixed Dose (FD)
Arm Type
Experimental
Arm Description
Subjects are allowed to titrate oral treprostinil up to a maximum dose of 1 mg TID.
Intervention Type
Drug
Intervention Name(s)
Oral treprostinil
Other Intervention Name(s)
Orenitram
Intervention Description
Oral treprostinil will be administered as TID dosing for up to 16 Weeks.
Primary Outcome Measure Information:
Title
Change in pulmonary vascular resistance (PVR)
Description
Change in PVR between iMTD and fixed dose groups
Time Frame
Baseline to Week 16
Secondary Outcome Measure Information:
Title
Change in Six-minute walk distance (6MWD)
Description
Change in 6MWD between iMTD and fixed dose groups
Time Frame
Baseline to Week 16
Title
Change in N-terminal pro-brain natriuretic peptide (NT-ProBNP)
Description
Change in NT-ProBNP between iMTD and fixed dose groups
Time Frame
Baseline to Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajan Saggar, MD
Organizational Affiliation
University of California, Los Angeles - Pulmonary Division
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner University Medical Center Phoenix Advanced Lung Disease
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
University of California, Los Angeles - Pulmonary Division
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
University of California - Davis Medical Group
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Johns Hopkins University
City
Baltiomore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
CLC Pulmonary Hypertension Clinic Division of Pulmonary, Allergy and Critical Care Medicine UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Study is withdrawn. There is no data to share.

Learn more about this trial

Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis

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