Pulmonary Arterial Hypertension
Conditions
Keywords
Oral Treprostinil, Remodulin, Selexipag, 6 Minute Walk Test
Brief summary
This is a multicenter, single-arm trial to evaluate the safety of the transition from Selexipag to Remodulin® then Oral Treprostinil in Symptomatic Subjects with Pulmonary Arterial Hypertension (PAH). The study will include about 30 subjects at approximately 10 clinical trial centers. The treatment phase of the study will last approximately 16 weeks.
Interventions
DRUGParenteral Remodulin (treprostinil) injection
Remodulin will be provided in vial strengths of 1, 2.5, 5, and 10 mg/mL. Subjects will be admitted to the hospital and IV Remodulin will be initiated within 12 hours after the last dose of selexipag. Subjects will remain under observation in the inpatient setting for at least the first 72 hours of Remodulin administration. Subjects will be transitioned to an equivalent dose of SC Remodulin at discharge.
Oral treprostinil will be provided as 0.125-, 0.25-, 1-, or 2.5-mg extended-release tablets. Oral treprostinil will be dosed three times daily with food.
Sponsors
United Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subject has a diagnosis of symptomatic idiopathic or heritable PAH, PAH associated with connective tissue disease, PAH associated with HIV infection, PAH associated with repaired congenital systemic-to-pulmonary shunt (at least 1 year since repair with respect to the date of providing informed consent), or PAH associated with appetite suppressant or toxin use. 2. The subject must be classified as WHO FC II or III at Baseline. 3. The subject is receiving selexipag for the treatment of WHO Group 1 PAH for a minimum of 90 days from Baseline. 4. Subject is in need of escalation of therapy, as determined by the Investigator. 5. Subject must be receiving a Food and Drug Administration (FDA)-approved PDE5-I or sGC stimulator and/or an ERA and has been at the current stable dose for at least 28 days prior to Baseline.
Exclusion criteria
1. The subject is receiving selexipag for any other disease or condition other than the treatment of WHO Group 1 PAH. 2. The subject has a Baseline 6MWD of less than 150 meters. 3. The subject's Baseline 6MWD has decreased more than 40% from the pre-selexipag baseline. 4. The subject has a history of ischemic heart disease (defined as either symptomatic or requiring anti-anginal therapy or experienced a documented myocardial infarction within the previous 6 months of Baseline), or a history of left sided myocardial dysfunction as evidenced by a PAWP greater than 15 mmHg or a left ventricular ejection fraction less than 40%. 5. The subject has previously been treated with any parenteral prostacyclin or oral treprostinil for a period of 90 days or more. 6. The subject has a history of 1 or more of the following signs of relevant lung disease within 180 days before Baseline: 1. Total lung capacity less than 60% of predicted normal. 2. Forced expiratory volume in 1 second is less than 55% of predicted normal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events (AEs) through 16 Weeks | 16 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in 6-minute Walk Distance (6MWD) from Baseline to Week 16 | Baseline and Week 16 |
| Change in Borg Dyspnea Score Immediately After 6-minute Walk Test (6MWT) from Baseline to Week 16 | Baseline and Week 16 |
| Change in plasma concentration of N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) from Baseline to Week 16 | Baseline and Week 16 |
| Change in Pulmonary Arterial Hypertension (PAH) Symptoms Score from Baseline to Week 16 | Baseline and Week 16 |
| Change in Score on Treatment Satisfaction Questionnaire for Medication (TSQM) from Baseline to Week 16 | Baseline and Week 16 |
Outcome results
None listed