Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2018-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pulmonary Hypertension Pulmonary Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Individual Maximum Tolerated Dose (iMTD)

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

Group Type EXPERIMENTAL

Oral treprostinil

Intervention Type DRUG

Oral treprostinil will be administered as TID dosing for up to 16 Weeks.

Fixed Dose (FD)

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

Group Type EXPERIMENTAL

Oral treprostinil

Intervention Type DRUG

Oral treprostinil will be administered as TID dosing for up to 16 Weeks.

Interventions

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Oral treprostinil

Oral treprostinil will be administered as TID dosing for up to 16 Weeks.

Intervention Type DRUG

Other Intervention Names

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Orenitram

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No