Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis

NCT02603068 | Withdrawn Phase 2

• 1 other identifier: TDE-PH-204
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 7

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.

Conditions

Pulmonary Hypertension; Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Change in pulmonary vascular resistance (PVR)

  Change in PVR between iMTD and fixed dose groups

  Baseline to Week 16

Secondary Outcomes (2)

• Change in Six-minute walk distance (6MWD)

  Baseline to Week 16

• Change in N-terminal pro-brain natriuretic peptide (NT-ProBNP)

  Baseline to Week 16

Study Arms (2)

Individual Maximum Tolerated Dose (iMTD)

EXPERIMENTAL

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

Drug: Oral treprostinil

Fixed Dose (FD)

EXPERIMENTAL

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

Drug: Oral treprostinil

Interventions

Oral treprostinil DRUG

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

Also known as: Orenitram

Fixed Dose (FD); Individual Maximum Tolerated Dose (iMTD)

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• MWD 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

You may not qualify if:

• 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

Sponsors & Collaborators

• United Therapeutics: lead

Study Sites (7)

Banner University Medical Center Phoenix Advanced Lung Disease

Phoenix, Arizona, 85006, United States

Location

University of California, Los Angeles - Pulmonary Division

Los Angeles, California, 90024, United States

Location

University of California - Davis Medical Group

Sacramento, California, 95817, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Johns Hopkins University

Baltiomore, Maryland, 21205, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

CLC Pulmonary Hypertension Clinic Division of Pulmonary, Allergy and Critical Care Medicine UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Fibrosis

Interventions

treprostinil

Condition Hierarchy (Ancestors)

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

Study Officials

• Rajan Saggar, MD

  University of California, Los Angeles - Pulmonary Division

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 10, 2015
• First Posted: November 11, 2015
• Study Start: February 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: July 1, 2018
• Last Updated: February 9, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)