Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis

Pulmonary Hypertension Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02603068
• Other study ID #: TDE-PH-204
• Status: Withdrawn
• Phase: Phase 2
• First received: November 10, 2015
• Last updated: February 5, 2016
• Start date: February 2016
• Est. completion date: July 2018

Study information

• Verified date: February 2016
• Source: United Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibrosis
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Fibrosis
• Pulmonary Hypertension

Intervention

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

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia
United States	Johns Hopkins University	Baltiomore	Maryland
United States	University of California, Los Angeles - Pulmonary Division	Los Angeles	California
United States	Banner University Medical Center Phoenix Advanced Lung Disease	Phoenix	Arizona
United States	CLC Pulmonary Hypertension Clinic Division of Pulmonary, Allergy and Critical Care Medicine UPMC	Pittsburgh	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	University of California - Davis Medical Group	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
United Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pulmonary vascular resistance (PVR)	Change in PVR between iMTD and fixed dose groups	Baseline to Week 16	Yes
Secondary	Change in Six-minute walk distance (6MWD)	Change in 6MWD between iMTD and fixed dose groups	Baseline to Week 16	No
Secondary	Change in N-terminal pro-brain natriuretic peptide (NT-ProBNP)	Change in NT-ProBNP between iMTD and fixed dose groups	Baseline to Week 16	No