A Phase 3, Randomized, Double-Blind, Placebo- Controlled Study to Evaluate Sotatercept When Added to Maximum Tolerated Background Therapy in Participants With Pulmonary Arterial Hypertension (PAH) World Health Organization (WHO) Functional Class (FC) III or FC IV at High Risk of Mortality

Date Added
January 20th, 2022
PRO Number
Pro00115261
Researcher
Rahul Argula

List of Studies


Keywords
Lung, Pulmonary, Pulmonary Hypertension
Summary

The objective of this study is to evaluate the effects of sotatercept treatment (plus maximum tolerated background PAH therapy) versus placebo (plus maximum tolerated background PAH therapy) on time to first event of all cause death, lung transplantation, or PAH worsening-related hospitalization of ≥ 24 hours, in participants with WHO FC III or FC IV PAH at high risk of mortality. The study targets patients with symptomatic PAH (WHO FC III or FC IV at high risk of mortality) who present with idiopathic or heritable PAH, PAH associated with connective tissue diseases (CTD), drug- or toxininduced, post-shunt correction PAH, or PAH presenting at least 1 year following the correction of congenital heart defect. Up to 166 participants will be randomly assigned in a 1:1 ratio to the
2 study treatment groups (83 participants per arm). Maximum study duration for a given participant in this study will be up to approximately 49 months.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
(843) 792-0965
shannonz@musc.edu

A Multicenter, Randomized, Double-blind, Placebo-controlled Study in Participants With Sarcoidosis-associated Pulmonary Hypertension (SAPH) to Assess the Efficacy and Safety of Oral Selexipag

Date Added
December 21st, 2021
PRO Number
Pro00115070
Researcher
Rahul Argula

List of Studies


Keywords
Pulmonary, Sarcoidosis
Summary

The purpose of this study is to evaluate the safety and efficacy of an investigational drug in adults with a clinical diagnosis of sarcoidosis-associated pulmonary hypertension. This study aims to determine if patients receiving an investigational study drug, called Selexipag, respond better than patients receiving placebo (an inactive substance). The study of this investigational drug represents a new approach to the treatment of this condition and may provide significant benefit in terms of the quality of life to patients with sarcoidosis-associated pulmonary hypertension. Participation in the study will last between approximately 15 months and up to approxiamately 3.5 years.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy in Newly Diagnosed Intermediate-and High-Risk PAH Patients

Date Added
October 6th, 2021
PRO Number
Pro00113186
Researcher
Rahul Argula

List of Studies


Keywords
Pulmonary, Pulmonary Hypertension
Summary

The objective of this study is to evaluate the effects of sotatercept treatment (plus background PAH therapy) verses placebo (plus background PAH therapy) on time to clinical worsening (TTCW) in participants who are newly diagnosed with PAH and are in intermediate or high risk of disease progression. The study is divided into a Screening Period (up to 4 weeks), followed by a Double-blind Placebo-controlled (DBPC) Treatment Period. When a participant experiences an event of clinical worsening, they will complete the End of Treatment (EOT) Visit and will be eligible to enroll immediately in the open-label, long-term follow-up (LTFU) study, A011-12 (SOTERIA). Up to 662 participants will be randomly assigned in a 1:1 ratio to the 2 study treatment groups (331 participants per arm).

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH

Date Added
August 4th, 2021
PRO Number
Pro00111327
Researcher
Rahul Argula

List of Studies


Keywords
Lung, Pulmonary, Pulmonary Hypertension
Summary

This open-label, LTFU study will evaluate the safety, tolerability, and efficacy of sotatercept in participants with PAH previously treated with sotatercept or placebo. Participants eligible to enroll in this study will have participated in and completed the relevant study participants of the parent PAH sotatercept clinical trials. The estimated duration of the A011-12 study is up to 7 years; however, the estimated duration of enrollment for each participants is approximately 4 years. There is no formal sample size calculation for the study. The number of participants in this LTFU study is dependent upon the enrollment in the parent protocols. Approximately 700 participants are anticipated to enroll in the study.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

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

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

List of Studies


Keywords
Lung, Pulmonary, Pulmonary Hypertension
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
Zerlinna Teague
(843) 792-0965
shannonz@musc.edu

Pulmonary Hypertension Association Registry (PHAR)

Date Added
March 18th, 2020
PRO Number
Pro00097483
Researcher
Rahul Argula

List of Studies


Keywords
Lung, Pulmonary, Pulmonary Hypertension
Summary

The PHAR is a multicenter, prospective registry of newly evaluated patients at PHCCs in the United States who have either PAH or CTEPH. Baseline information will be collected at the time of initial evaluation at the PHCC (within six months of the initial outpatient PHCC visit) with follow-up data collected at approximately 6-month intervals. This study will determine how patients with PH are evaluated, tested, and treated, and will observe how well patients do. The goal of the project is to see if patients with PH are treated according to recommended guidelines and to see if there are certain factors which lead to better or worse outcomes in patients with PH. There is no intervention or study medication used and there is no limitation to how a patient is treated in this study.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@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)

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

List of Studies


Keywords
Lung, Pulmonary, Pulmonary Hypertension
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
Zerlinna Teague
(843) 792-0965
shannonz@musc.edu

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL STUDY TO ASSESS THE SAFETY AND EFFICACY OF PULSED, INHALED NITRIC OXIDE (iNO) IN SUBJECTS WITH PULMONARY HYPERTENSION ASSOCIATED WITH PULMONARY FIBROSIS ON LONG TERM OXYGEN THERAPY (PART 1 AND PART 2)

Date Added
January 23rd, 2018
PRO Number
Pro00074258
Researcher
Rahul Argula

List of Studies


Keywords
Pulmonary Hypertension
Summary

The purpose of this study is to determine if the study drug, inhaled nitric oxide, when given and breathed through an investigational study device called the INOpulse, may help treat PF. Inhaled nitric oxide is a drug approved by the FDA and Health Canada for the treatment of infants who have difficulty breathing and have decreased oxygen in their blood associated with pulmonary hypertension. Inhaled nitric oxide and the INOpulse delivery device are investigational for the treatment of PF with and without pulmonary hypertension and are not currently an approved treatment. Because we do not know if this drug and device combination will treat PF, we need to compare it against a placebo (a pretend drug that has no effect on a person). To do this, we will put people taking part in this study into two groups. The groups are selected by chance, like a coin toss. Participants in one group will be given the study drug while participants in the other group will be given the pretend drug.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
843-792-0965
recruitment@musc.edu

National Biological Sample and Data Repository for Pulmonary Arterial Hypertension

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

List of Studies


Keywords
Pulmonary, Pulmonary Hypertension
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
Zerlinna Teague
8437920965
recruitment@musc.edu



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