This is a Phase 2 study to determine the efficacy and safety of an experimental study drug called sotatercept. Enrolled patients will receive either sotatercept or placebo (substance that is made to resemble drugs but does not contain an active drug) in combination with your current Pulmonary arterial hypertension (PAH) medication(s), which falls within currently accepted standard of care (SOC) for PAH. There are 4 parts to this research study, a screening period (28 days), a 6-month double-blind treatment period, an 18-month extension period, and an 8-week follow up period. If qualified to continue with treatment, the subject will receive subcutaneous (under the skin) injection(s) of the study treatment through a needle at each dosing visit (multiple injections may be required).
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.
The purpose of this study is to see how oral treprostinil works to treat PH associated with HFpEF. Oral treprostinil (brand name Orenitram) was approved by the United States Food and Drug Administration (FDA) in December 2013 for the treatment of pulmonary arterial hypertension (PAH). PAH means that the blood vessels going from the right side of the heart to the lungs (pulmonary arteries) have higher than normal pressure. PAH is a specific type of PH.
This study will evaluate the long-term safety of oral treprostinil and the effects of continued therapy on the ability to exercise.
This study will look at the effect that oral treprostinil has on your ability to exercise and on the time that your PH associated with HFpEF remains stable, improves, or worsens. It will also evaluate the safety of using oral treprostinil to treat PH associated with HFpEF when added to your currently prescribed medication therapy.
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.
Patients with connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) are eligible for this study. This double-blind, randomized, placebo-controlled trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with WHO Group I CTD-PAH. Qualified patients will be randomized 1:1 to either bardoxolone methyl or placebo to be administered once daily for 24 weeks. Depending on the length of the screening period, the length of time inolved in study procedures is approximately 32 to 44 weeks.
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.
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.
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.
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.