An Open-Label Extension Study of Inhaled Treprostinil in Patients with Pulmonary Hypertension due to Chronic Obstructive Pulmonary Disease (PH-COPD) Save

Date Added
March 24th, 2020
PRO Number
Pro00097579
Researcher
Rahul Argula

List of Studies


Profiles_link
Keywords
Lung, Pulmonary, Pulmonary Arterial Hypertension (PAH)
Summary

The purpose of this study is to assess safety of the study drug, inhaled treprostinil, and the ability to tolerate long-term treatment with the study drug in patients with PH-COPD. The study will also evaluate the effectiveness of the study drug over long-term treatment. Inhaled treprostinil is a medication that will be given to you by a handheld inhalation device (study nebulizer) called the Tyvaso® Inhalation System. The study is estimated to last 2 to 3 years but could be much shorter or longer. Depending on the final number of subjects who participated in the RIN-PH-304 study, either approximately 136 or approximately 314 subjects may be eligible to participate in this study from the U.S. study centers.

Institution
MUSC
Recruitment Contact
April Rasberry
(843) 792-2375
rasberry@musc.edu

A Phase 3, Randomized, Placebo-controlled, Double-blind, Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Patients with Pulmonary Hypertension due to Chronic Obstructive Pulmonary Disease (PH-COPD) Save

Date Added
July 23rd, 2019
PRO Number
Pro00090282
Researcher
Rahul Argula

List of Studies


Profiles_link
Keywords
Lung, Pulmonary, Pulmonary Arterial Hypertension (PAH)
Summary

The purpose of this study is to evaluate the effectiveness of inhaled treprostinil in improving exercise ability in patients with PH (Pulmonary Hypertension) -COPD (Chronic Obstructive Pulmonary Disease) when compared to an inactive solution, or placebo. This is a 34-week study. Approximately 136 subjects will be enrolled at approximately 60 US centers in the Original Design. If the study is adapted to the Contingent Design, approximately 314 subjects will be enrolled at approximately 80 US centers.

Institution
MUSC
Recruitment Contact
Abbi Reed
(843) 792-1820
reedab@musc.edu

Cardiac biopsies in pulmonary hypertension Save

Date Added
August 21st, 2018
PRO Number
Pro00077070
Researcher
Ryan Tedford

List of Studies

Silhouette
Keywords
Pulmonary Arterial Hypertension (PAH), Scleroderma
Summary

Patients with systemic sclerosis (SSc) related pulmonary arterial hypertension (SScPAH) have a worse prognosis than those with idiopathic PAH. We have recently discovered that heart cells in SScPAH do not contract or squeeze as well as in other forms of pulmonary hypertension. However, the mechanism leading to this dysfunction is not understood. To better study this and in hopes of developing a future therapy, we plan to collect tissue samples via a heart biopsy at the time of a clinically indicated heart catheterization.

Institution
MUSC
Recruitment Contact
Brandon Sykes
843-792-1105
sykesb@musc.edu

An Extended Access Program To Assess Long-Term Safety Of Bardoxolone Methyl In Patients With Pulmonary Hypertension Save

Date Added
May 23rd, 2017
PRO Number
Pro00066024
Researcher
Rahul Argula

List of Studies


Profiles_link
Keywords
Lung, Pulmonary, Pulmonary Arterial Hypertension (PAH)
Summary

This extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with pulmonary hypertension (PH) who previously participated in controlled clinical studies with bardoxolone methyl.
Qualified patients will receive 10 mg of bardoxolone methyl once daily until the drug is available through commercial channels (including reimbursement) or until patient withdrawal, whichever. Dose de-escalation (down to 5 mg) is permitted during the study, if indicated clinically. All patients in the study will follow the same visit and assessment schedule. Patients will be scheduled to be assessed in person during treatment at Day 1, Week 4, Week 24, and every 24 weeks thereafter.
Patients will also be assessed by telephone contact on Day 10. Day 1 for this extended access study should occur on the same day as the last visit in the controlled clinical study. Assessments required for both the last visit in the controlled study and Day 1 for this study should only be completed once.

Institution
MUSC
Recruitment Contact
Courtney Rowley
843-792-8092
rowle@musc.edu

National Biological Sample and Data Repository for Pulmonary Arterial Hypertension Save

Date Added
October 18th, 2016
PRO Number
Pro00058433
Researcher
Rahul Argula

List of Studies


Profiles_link
Keywords
Pulmonary, Pulmonary Arterial Hypertension (PAH)
Summary

Subjects with Pulmonary Arterial Hypertension (PAH) will be asked to have blood drawn at their standard of care visit. Children (11 years and older) and adults are eligible. This study is voluntary. Blood samples obtained and the associated blood products and clinical/genetic data will be in the research study for a minimum of five years.

Institution
MUSC
Recruitment Contact
Ashley Warden
843-792-4349
jonesash@musc.edu

A PHASE 2 MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO ASSESS THE SAFETY AND EFFICACY OF IFETROBAN IN PATIENTS WITH DIFFUSE CUTANEOUS SYSTEMIC SCLEROSIS OR SYSTEMIC SCLEROSIS-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION Save

Date Added
October 11th, 2016
PRO Number
Pro00059217
Researcher
Richard Silver

List of Studies


Profiles_link
Keywords
Drug Studies, Pulmonary Arterial Hypertension (PAH), Scleroderma
Summary

A 52 week trial to evaluate the safety and effectiveness of the study drug ifetroban versus placebo, in treating patients with diffuse cutaneous systemic sclerosis or systemic sclerosis associated Pulmonary Arterial Hypertension. Subjects over age 18, with disease duration 60 months or less, along with other inclusion criteria will receive study drug or placebo for one year, along with safety testing.

Institution
MUSC
Recruitment Contact
Kelley Kajdasz
843-792-5290
gibsonke@musc.edu

An Open-Label Extension study of Inhaled Treprostinil in Subjects with Pulmonary Hypertension due to Parenchymal Lung Disease Save

Date Added
September 27th, 2016
PRO Number
Pro00057441
Researcher
Rahul Argula

List of Studies


Profiles_link
Keywords
Drug Studies, Lung, Pulmonary, Pulmonary Arterial Hypertension (PAH)
Summary

The purpose of this research study is to provide or continue to provide inhaled treprostinil to eligible subjects who participated in the RIN-PH-201 study. The study will also investigate the safety and how well inhaled treprostinil works in subjects with pulmonary hypertension associated with interstitial lung disease or combined pulmonary fibrosis and emphysema. This study will look at the ability to exercise after taking the study drug. Adults over the age of 18 are eligible. This study is voluntary and will last until you discontinue from the study or the study ends.

Institution
MUSC
Recruitment Contact
Ashley Warden
843-792-4349
jonesash@musc.edu

A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Subjects with Pulmonary Hypertension due to Parenchymal Lung Disease Save

Date Added
July 26th, 2016
PRO Number
Pro00057087
Researcher
Rahul Argula

List of Studies


Profiles_link
Keywords
Drug Studies, Lung, Pulmonary, Pulmonary Arterial Hypertension (PAH)
Summary

The purpose of this study is to investigate the safety and how well inhaled treprostinil works in subjects with pulmonary hypertension associated with interstitial lung disease or combined pulmonary fibrosis and emphysema. Adults over the age of 18 are eligible. Study requires at least 6 separate clinic visits over approximately a 20 week period.

Institution
MUSC
Recruitment Contact
Ashley Warden
843-792-4349
jonesash@musc.edu

OPUS Registry Opsumit® (macitentan) USers Registry Save

Date Added
November 18th, 2014
PRO Number
Pro00039449
Researcher
Rahul Argula

List of Studies


Profiles_link
Keywords
Lung, Pulmonary, Pulmonary Arterial Hypertension (PAH)
Summary

Pulmonary arterial hypertension subjects who are new users of Opsumit®
can participate in this observational registry. All patients being prescribed to take Opsumit® will be invited to participate in the OPUS registry

The OPUS registry will collect information on patients newly treated with Opsumit® in the United States. If you agree to participate in the OPUS registry, information about your disease and the treatment of your disease will be collected for at least 1 year and stored electronically, from the date that you agree to enroll in the OPUS registry.

As this is an information-gathering study only, participating in the OPUS registry will not influence the usual care that you receive from your doctor.The data collected on patients will include retrospective data, if applicable (data from medical records that were recorded prior to start of the OPUS registry) and follow-up clinic visit data. Thereafter, your medical data will be collected when you see your doctor at routine visits, or during a potential hospitalization.

Institution
MUSC
Recruitment Contact
Elizabeth Poindexter
843-792-1820
poindex@musc.edu

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